Obstructive Sleep Apnea
Conditions
Keywords
Sleep Apnea, Heart Disease, Risk factors for heart disease
Brief summary
Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing heart disease or may already have a diagnosis of heart disease. A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups: 1. Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical treatment for sleep apnea with active-PAP. Participants will be randomized to either: 1. Active-Pap with respiratory therapist visits only 2. Active-Pap with respiratory therapist visits and cognitive behavioral therapist visits. 2. Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP therapy group. Will also have meetings with respiratory therapist. 3. Conservative Medical Therapy Group (CMT)\*: Will receive a free supply of nasal strips for the duration of their treatment period (either 6 months or 12 months) and follow healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences of apneas (breathing disturbances during sleep). Frequent follow-up support with research coordinator. A sleep doctor or cardiologist will have indicated that a potential participant is an appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed heart disease or between 55-75 years for those who have risk factors for developing heart disease. This is a 6-12 month study\*\* to evaluate alternative ways to address the potential for OSA treatment to reduce heart disease and to identify those features that would strengthen a later, large-scale randomized controlled trial. We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and mortality. \*All randomized participants will be given conservative medical therapy (CMT). \*\*For those randomized after December 31, 2012, follow-up assessment will only be 6 months long
Detailed description
In this pilot randomized controlled trial, we will assess the effectiveness of CPAP therapy to reduce the burden of cardiovascular disease (CVD) and CVD risk factors in patients with moderate to severe obstructive sleep apnea (OSA) presenting to a sleep disorders clinic. A total of 700 patients with a new diagnosis of moderate to severe OSA will be recruited from BWH-affiliated sleep disorder clinics, BWH, Massachusetts General Hospital (MGH), and Faulkner Hospital Cardiology Clinics (and similar specialized clinics seeing patients with cardiovascular risk factors, such as endocrinology and hypertensive clinics), Beth Israel Deaconess Medical Center and Joslin Diabetes Center. After completing a 2 week run-in period, randomized participants (approximately 150 participants will be randomized) will undergo baseline and 6 month assessments of key study exposure and outcome variables. Participants will be randomized after completion of Baseline visit. The treatment arms are as follows: The active arms are: 1. Active-PAP treatment delivered using standard respiratory therapist (RT) adherence education and support. (Active-Beh) 2. Active-PAP treatment administered using adherence education and support delivered by a RT and enhanced by a behavioral promotion intervention. (Active+Beh) The control arms are: 1. Conservative Medical Therapy (CMT) 2. Sham-PAP (Sham) Participants randomized before December 31, 2012 (n=108) also will undergo 12 month follow-up assessments. Participants will be offered a 12 month supervised conservative medical therapy (CMT) program for OSA over the duration of the study intervention. Subjects would be contacted at bimonthly intervals by alternating phone and office visits to assess safety, identify adverse events, identify health care utilization, and reinforce protocol adherence. At 6 and 12 months, study outcomes will be reassessed by collecting data from sources. Patients randomized after December 31, 2012 (n=61) will undergo only 6 months of follow-up assessment. Participants will be offered a 6 month supervised conservative medical therapy (CMT) program for OSA over the duration of the study intervention. Subjects would be contacted at bimonthly intervals by alternating phone and office visits to assess safety, identify adverse events, identify health care utilization, and reinforce protocol adherence. At 6 months, study outcomes will be reassessed by collecting data from sources.
Interventions
BEHAVIORALConservative Medical Therapy (CMT)
All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
DEVICESham PAP (Sham)
In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
DEVICEActive PAP with RT Support (Active-Beh)
In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The CPAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
DEVICEActive PAP with Behavioral Modification (Active+Beh)
In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
Sponsors
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Obstructive apnea hypopnea index (AHI) ≥ 15 * Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD) * Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention. * Established CVD,or having diabetes mellitus, defined by one or more of the following: 1. Prior myocardial infarction 2. Coronary artery revascularization procedure (≥4 months before study entry) 3. Angiographically documented stenosis (\>70%) of a major coronary artery 4. Prior ischemic stroke without major functional impairment 5. Diabetes mellitus treated with medication or ≥ 2 fasting glucose levels ≥ 126 mg/dl OR Three or more of the following established CVD risk factors: 1. Hypertension treated with medications or systolic BP \> 140 or diastolic BP \> 90 on ≥ 2 occasions 2. Male sex 3. BMI ≥ 30 4. Total cholesterol \> 240 mg/dl or LDL cholesterol \> 160 mg/dl or HDL \< 45 mg/dl 5. \> 10 pack years of smoking
Exclusion criteria
* Diagnosed heart failure with known cardiac ejection fraction of \< 35% or New York Heart Association (NYHA) class 3 or 4 status * Less than 4 months since myocardial infarction (MI), stroke or revascularization procedure * Poorly controlled hypertension (\>170/\>100) * Prior stroke with functional impairment interfering with ability to complete the protocol * Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. oral steroids; chronic opioid use; self- reported chronic kidney disease or, if measured, creatinine \> 2.5 mg/dl or glomerular filtration rate (GFR) \< 30; anemia with Hgb \< 10, etc.) * Resting oxygen saturation \< 90% or nocturnal oxygen saturation \<85% for \> 10% of the sleep period; * Use of prescribed PAP for sleep apnea within the prior 2 years * Report of inability to spend \>6 hrs in bed * Any use of prescribed PAP for sleep apnea * Severe sleepiness defined by an Epworth Sleepiness Score of \>14 or report of falling asleep driving in the prior 2 years * Working as a professional driver * Low risk related to having sleep apnea defined by a Berlin Score \< 2 * Central sleep apnea, with \>50% of respiratory events classified as central apneas * Refusal to consider PAP use after an initial split-night PAP study (pre-randomization) * Concurrent involvement in another research study that will result in a conflict as determined by study doctors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Mean of 6- and 12-months | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis. |
| Difference in CPAP Adherence by Active Treatment Arm | 6-months | Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization. |
| Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Mean of 6- and 12-months | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months. |
| Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 12-months | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis. |
| Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 6-months | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis. |
| Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 12-months | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months. |
| Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 6-months | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | Mean of 6- and 12-months | Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Augmentation Index at Months 6 and 12 (4 Arms) | Mean of 6- and 12-months | Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Left Ventricular (LV) Mass Index (4 Arm) - Baseline | 12-months | Baseline Left Ventricular Mass Index measured via echocardiography. |
| Left Atrial (LA) Volume Index (4 Arm) - Baseline | 12-months | Baseline Left Atrial Mass Index measured via echocardiography. |
| End-Diastolic Volume (4 Arm) - Baseline | 12-months | Baseline End-Diastolic Volume measured via echocardiography. |
| Ejection Fraction (4 Arm) - Baseline | 12-months | Baseline Ejection Fraction measured via echocardiography. |
| Right Ventricular Fractional Area Change (4 Arm) - Baseline | 12-months | Baseline RV Fractional Area Change measured via echocardiography. |
| Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | 12-months | Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography. |
| Pulmonary Vascular Resistance (4 Arm) - Baseline | 12-months | Baseline Pulmonary Vascular Resistance measured via echocardiography. |
| E/Em Lateral Ratio (4 Arm) - Baseline | 12-months | Baseline E/Em Lateral Ratio measured via echocardiography. |
| Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | 12-months | Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography. |
| Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | Mean of 6- and 12-months | The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Left Atrial Volume Index (4 Arm) - 12 Month | 12-months | Endpoint Left Atrial Volume Index measured via echocardiography. |
| End-Diastolic Volume (4 Arm) - 12 Month | 12-months | Endpoint End-Diastolic Volume measured via echocardiography. |
| Ejection Fraction (4 Arm) - 12 Month | 12-months | Endpoint Ejection Fraction measured via echocardiography. |
| Right Ventricular Fractional Area Change (4 Arm) - 12 Month | 12-months | Endpoint Right Ventricular Fractional Area Change measured via echocardiography. |
| Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | 12-months | Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography. |
| Pulmonary Vascular Resistance (4 Arm) - 12 Month | 12-months | Endpoint Pulmonary Vascular Resistance measured via echocardiography. |
| E/Em Lateral Ratio (4 Arm) - 12 Month | 12-months | Endpoint E/Em Lateral Ratio measured via echocardiography. |
| Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 12-months | 12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography. |
| Left Ventricular Mass Index (4 Arm) - 12 Month | 12-months | Endpoint Left Ventricular Mass Index measured via echocardiography. |
| Change in Epworth Sleepiness Scale (ESS) (4 Arm) | Mean of 6- and 12-months | The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Patient Health Questionnaire (PHQ8) (4 Arm) | Mean of 6- and 12-months | The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | Mean of 6- and 12-months | The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Lipid Panel at 6 and 12 Months (4 Arm) | Mean of 6- and 12-months | Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
| Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Mean of 6- and 12-months | Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. |
Countries
United States
Participant flow
Recruitment details
Initial recruitment was limited to patients with sleep apnea identified through clinical sleep programs of Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Recruitment later expanded to include patients presenting to cardiology and diabetes clinics. Recruitment began on April 2011 and ended on June 2013.
Pre-assignment details
Patients with no sleep study were provided a portable sleep monitor to measure the severity (if any) of obstructive sleep apnea (OSA). If tests shows moderate to severe OSA, patients were asked to wear a positive airway pressure (PAP) mask with no pressure for 2 weeks. Those with proven adherence during this time were scheduled for a baseline visit
Participants by arm
| Arm | Count |
|---|---|
| Conservative Medical Therapy (CMT) All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate. | 44 |
| Sham PAP (Sham) In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms. | 42 |
| Active PAP With RT Support (Active-Beh) In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes. | 42 |
| Active PAP With Behavioral Modification (Active+Beh) In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training. | 41 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Dissatisfaction with Treatment | 2 | 1 | 1 | 2 |
| Overall Study | Loss of Interest in the Study | 3 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 6 | 5 | 6 |
| Overall Study | Relocation | 0 | 1 | 0 | 0 |
| Overall Study | Significant Concurrent Illness | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Sham PAP (Sham) | Conservative Medical Therapy (CMT) | Total | Active PAP With Behavioral Modification (Active+Beh) | Active PAP With RT Support (Active-Beh) |
|---|---|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 7.5 | 64.0 years STANDARD_DEVIATION 6.3 | 63.6 years STANDARD_DEVIATION 7.3 | 63.6 years STANDARD_DEVIATION 8.2 | 63.7 years STANDARD_DEVIATION 7.3 |
| AHI | 31.5 respiratory events per hour STANDARD_DEVIATION 20 | 33.9 respiratory events per hour STANDARD_DEVIATION 21.8 | 30.0 respiratory events per hour STANDARD_DEVIATION 17.4 | 26.8 respiratory events per hour STANDARD_DEVIATION 12.4 | 27.6 respiratory events per hour STANDARD_DEVIATION 12.5 |
| Baseline 24-Hour Blood Pressure Data by Arm 24-hour Mean Arterial Pressure | 92.0 mmHg STANDARD_DEVIATION 8.7 | 90.7 mmHg STANDARD_DEVIATION 9.8 | 90.3 mmHg STANDARD_DEVIATION 8.2 | 89.2 mmHg STANDARD_DEVIATION 7.4 | 89.3 mmHg STANDARD_DEVIATION 6.5 |
| Baseline 24-Hour Blood Pressure Data by Arm 24-hour Systolic Blood Pressure | 128.1 mmHg STANDARD_DEVIATION 14.4 | 125.4 mmHg STANDARD_DEVIATION 14.3 | 124.1 mmHg STANDARD_DEVIATION 12.8 | 121.8 mmHg STANDARD_DEVIATION 11 | 121.3 mmHg STANDARD_DEVIATION 10.4 |
| Baseline 24-Hour Blood Pressure Data by Arm Sleep Mean Arterial Pressure | 84.7 mmHg STANDARD_DEVIATION 11.2 | 83.3 mmHg STANDARD_DEVIATION 12.4 | 82.7 mmHg STANDARD_DEVIATION 10.6 | 81.5 mmHg STANDARD_DEVIATION 10.2 | 81.1 mmHg STANDARD_DEVIATION 8 |
| Baseline Echocardiogram Measures by Arm - Augmentation Index | 30.2 percent of central pulse pressure STANDARD_DEVIATION 9.7 | 30.6 percent of central pulse pressure STANDARD_DEVIATION 9.6 | 30.1 percent of central pulse pressure STANDARD_DEVIATION 9.3 | 29.8 percent of central pulse pressure STANDARD_DEVIATION 8.7 | 29.8 percent of central pulse pressure STANDARD_DEVIATION 9.3 |
| Baseline Echocardiogram Measures by Arm - Ejection Fraction | 60.9 percent ejection fraction STANDARD_DEVIATION 2.7 | 60.2 percent ejection fraction STANDARD_DEVIATION 4.1 | 60.5 percent ejection fraction STANDARD_DEVIATION 4.7 | 59.9 percent ejection fraction STANDARD_DEVIATION 4.6 | 60.8 percent ejection fraction STANDARD_DEVIATION 6.6 |
| Baseline Echocardiogram Measures by Arm - Pulse Wave Velocity | 9.7 m/s STANDARD_DEVIATION 2.4 | 9.6 m/s STANDARD_DEVIATION 2.1 | 9.3 m/s STANDARD_DEVIATION 2.1 | 9.4 m/s STANDARD_DEVIATION 1.8 | 8.6 m/s STANDARD_DEVIATION 1.8 |
| Baseline Laboratory Measures by Arm - CRP | 5.6 mg/L STANDARD_DEVIATION 17.6 | 3.9 mg/L STANDARD_DEVIATION 9 | 4.3 mg/L STANDARD_DEVIATION 11.2 | 3.0 mg/L STANDARD_DEVIATION 2.7 | 4.5 mg/L STANDARD_DEVIATION 10.4 |
| Baseline Laboratory Measures by Arm - Triglyceride and HDL HDL | 50.0 mg/dL STANDARD_DEVIATION 12.2 | 49.1 mg/dL STANDARD_DEVIATION 14.9 | 50.5 mg/dL STANDARD_DEVIATION 14.6 | 47.4 mg/dL STANDARD_DEVIATION 12.9 | 55.7 mg/dL STANDARD_DEVIATION 16.9 |
| Baseline Laboratory Measures by Arm - Triglyceride and HDL Triglyceride | 125.8 mg/dL STANDARD_DEVIATION 61.6 | 130.3 mg/dL STANDARD_DEVIATION 85.8 | 127.0 mg/dL STANDARD_DEVIATION 73.2 | 143.8 mg/dL STANDARD_DEVIATION 81.8 | 108.3 mg/dL STANDARD_DEVIATION 57.1 |
| Baseline Quality of Life Measures by Arm - ESS | 8.0 units on a scale STANDARD_DEVIATION 4.2 | 9.0 units on a scale STANDARD_DEVIATION 4.9 | 8.3 units on a scale STANDARD_DEVIATION 4.5 | 8.4 units on a scale STANDARD_DEVIATION 4.8 | 7.8 units on a scale STANDARD_DEVIATION 4.2 |
| Baseline Quality of Life Measures by Arm - PHQ-8 | 5.1 units on a scale STANDARD_DEVIATION 4.1 | 5.0 units on a scale STANDARD_DEVIATION 4.6 | 5.3 units on a scale STANDARD_DEVIATION 4.9 | 6.4 units on a scale STANDARD_DEVIATION 5.6 | 4.7 units on a scale STANDARD_DEVIATION 5.1 |
| Baseline Quality of Life Measures by Arm - SAQLI | 4.8 units on a scale STANDARD_DEVIATION 0.8 | 4.8 units on a scale STANDARD_DEVIATION 0.8 | 4.8 units on a scale STANDARD_DEVIATION 0.9 | 4.7 units on a scale STANDARD_DEVIATION 1 | 4.9 units on a scale STANDARD_DEVIATION 0.9 |
| Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) SF-36 Emotional Subscale | 44.9 units on a scale STANDARD_DEVIATION 12.3 | 47.9 units on a scale STANDARD_DEVIATION 10.7 | 46.7 units on a scale STANDARD_DEVIATION 11.6 | 45.5 units on a scale STANDARD_DEVIATION 12.3 | 48.4 units on a scale STANDARD_DEVIATION 11.1 |
| Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) SF-36 Physical Subscale | 44.3 units on a scale STANDARD_DEVIATION 10.7 | 44.1 units on a scale STANDARD_DEVIATION 10.9 | 45.0 units on a scale STANDARD_DEVIATION 10.6 | 44.4 units on a scale STANDARD_DEVIATION 10.9 | 47.1 units on a scale STANDARD_DEVIATION 10 |
| Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) SF-36 Vitality Subscale | 48.0 units on a scale STANDARD_DEVIATION 9.7 | 49.6 units on a scale STANDARD_DEVIATION 10.1 | 48.9 units on a scale STANDARD_DEVIATION 9.9 | 48.7 units on a scale STANDARD_DEVIATION 9.6 | 49.0 units on a scale STANDARD_DEVIATION 10.4 |
| Baseline Resting Blood Pressure Data by Arm Average Resting Diastolic | 68.6 mmHg STANDARD_DEVIATION 8.5 | 70.1 mmHg STANDARD_DEVIATION 8.6 | 70.3 mmHg STANDARD_DEVIATION 9.2 | 71.3 mmHg STANDARD_DEVIATION 8.9 | 71.2 mmHg STANDARD_DEVIATION 10.6 |
| Baseline Resting Blood Pressure Data by Arm Average Resting Systolic | 123.6 mmHg STANDARD_DEVIATION 18.1 | 125.1 mmHg STANDARD_DEVIATION 15.3 | 125.2 mmHg STANDARD_DEVIATION 17.2 | 127.5 mmHg STANDARD_DEVIATION 16.2 | 124.8 mmHg STANDARD_DEVIATION 19.5 |
| BMI | 32.1 kg/m^2 STANDARD_DEVIATION 5.7 | 32.4 kg/m^2 STANDARD_DEVIATION 7.2 | 31.7 kg/m^2 STANDARD_DEVIATION 5.9 | 31.6 kg/m^2 STANDARD_DEVIATION 5.9 | 30.6 kg/m^2 STANDARD_DEVIATION 4.5 |
| Cardiovascular Disease (CVD) Status CVD Risk Factors | 17 participants | 20 participants | 72 participants | 18 participants | 17 participants |
| Cardiovascular Disease (CVD) Status Established CVD | 25 participants | 24 participants | 97 participants | 23 participants | 25 participants |
| Diagnostic Type Full-Night | 39 participants | 41 participants | 157 participants | 38 participants | 39 participants |
| Diagnostic Type Split-Night | 3 participants | 3 participants | 12 participants | 3 participants | 3 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 6 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 43 Participants | 163 Participants | 38 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 11 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 41 Participants | 151 Participants | 37 Participants | 37 Participants |
| Sex: Female, Male Female | 19 Participants | 12 Participants | 59 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Male | 23 Participants | 32 Participants | 110 Participants | 27 Participants | 28 Participants |
| Waist Circumference | 112.6 cm STANDARD_DEVIATION 14.5 | 110.2 cm STANDARD_DEVIATION 16.1 | 110.4 cm STANDARD_DEVIATION 14.1 | 110.6 cm STANDARD_DEVIATION 13.3 | 108.3 cm STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 44 | 22 / 42 | 16 / 42 | 18 / 41 |
| serious Total, serious adverse events | 7 / 44 | 5 / 42 | 2 / 42 | 4 / 41 |
Outcome results
Primary
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms)
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Systolic Blood Pressure | -0.97 mmHg | Standard Deviation 15.36 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Diastolic Blood Pressure | -0.68 mmHg | Standard Deviation 7.32 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Mean Arterial Pressure | -0.78 mmHg | Standard Deviation 9.9 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Systolic Blood Pressure | 0.40 mmHg | Standard Deviation 22.7 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Diastolic Blood Pressure | -0.52 mmHg | Standard Deviation 10.47 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Mean Arterial Pressure | -0.51 mmHg | Standard Deviation 14 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Systolic Blood Pressure | -1.91 mmHg | Standard Deviation 14.84 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Diastolic Blood Pressure | -0.91 mmHg | Standard Deviation 7.6 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Mean Arterial Pressure | -1.44 mmHg | Standard Deviation 10.54 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Diastolic Blood Pressure | -0.62 mmHg | Standard Deviation 6.15 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Systolic Blood Pressure | 2.22 mmHg | Standard Deviation 18.36 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Diastolic Blood Pressure | 0.40 mmHg | Standard Deviation 5.29 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Mean Arterial Pressure | 1.01 mmHg | Standard Deviation 8.68 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Mean Arterial Pressure | 2.57 mmHg | Standard Deviation 11.21 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Systolic Blood Pressure | 5.48 mmHg | Standard Deviation 20.82 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Systolic Blood Pressure | 0.74 mmHg | Standard Deviation 18.87 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Diastolic Blood Pressure | 1.97 mmHg | Standard Deviation 9.53 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Mean Arterial Pressure | -0.005 mmHg | Standard Deviation 8.92 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Mean Arterial Pressure | -1.10 mmHg | Standard Deviation 6.64 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Systolic Blood Pressure | -0.75 mmHg | Standard Deviation 15.15 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Systolic Blood Pressure | -0.09 mmHg | Standard Deviation 10.42 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Diastolic Blood Pressure | -2.54 mmHg | Standard Deviation 9.17 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Diastolic Blood Pressure | -2.25 mmHg | Standard Deviation 8 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Mean Arterial Pressure | -2.88 mmHg | Standard Deviation 11.44 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Diastolic Blood Pressure | -1.61 mmHg | Standard Deviation 5 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Systolic Blood Pressure | -3.79 mmHg | Standard Deviation 17.02 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Mean Arterial Pressure | -1.59 mmHg | Standard Deviation 9.91 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Diastolic Blood Pressure | -2.06 mmHg | Standard Deviation 5.55 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Systolic Blood Pressure | 1.94 mmHg | Standard Deviation 10.17 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Mean Arterial Pressure | -0.71 mmHg | Standard Deviation 4.28 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Diastolic Blood Pressure | -0.11 mmHg | Standard Deviation 6.12 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Sleep Mean Arterial Pressure | 0.91 mmHg | Standard Deviation 6.71 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Mean Arterial Pressure | -0.87 mmHg | Standard Deviation 5.78 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Wake Systolic Blood Pressure | -0.02 mmHg | Standard Deviation 7.27 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Systolic Blood Pressure | 0.45 mmHg | Standard Deviation 7.41 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | 24-hour Diastolic Blood Pressure | -1.53 mmHg | Standard Deviation 5.4 |
Primary
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 24-hour Systolic Blood Pressure | 0.37 mmHg | Standard Deviation 16.52 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Sleep Systolic Blood Pressure | 2.61 mmHg | Standard Deviation 21.74 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Sleep Diastolic Blood Pressure | 0.57 mmHg | Standard Deviation 10.02 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Sleep Mean Arterial Pressure | 0.83 mmHg | Standard Deviation 12.79 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Wake Systolic Blood Pressure | -0.71 mmHg | Standard Deviation 16.6 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Wake Diastolic Blood Pressure | -0.78 mmHg | Standard Deviation 6.9 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Wake Mean Arterial Pressure | -0.80 mmHg | Standard Deviation 9.75 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 24-hour Diastolic Blood Pressure | -0.22 mmHg | Standard Deviation 6.48 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 24-hour Mean Arterial Pressure | -0.03 mmHg | Standard Deviation 9.33 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Sleep Diastolic Blood Pressure | -1.39 mmHg | Standard Deviation 7.87 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 24-hour Mean Arterial Pressure | -0.99 mmHg | Standard Deviation 6.15 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Wake Diastolic Blood Pressure | -2.16 mmHg | Standard Deviation 6.82 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Sleep Systolic Blood Pressure | -1.09 mmHg | Standard Deviation 14.31 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 24-hour Diastolic Blood Pressure | -1.57 mmHg | Standard Deviation 5.12 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Wake Mean Arterial Pressure | -1.16 mmHg | Standard Deviation 7.61 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Sleep Mean Arterial Pressure | -1.10 mmHg | Standard Deviation 9.57 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | 24-hour Systolic Blood Pressure | 0.17 mmHg | Standard Deviation 8.95 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Wake Systolic Blood Pressure | -0.40 mmHg | Standard Deviation 11.82 |
Primary
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms)
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months.
Time frame: 6-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Diastolic Blood Pressure | 1.46 mmHg | Standard Deviation 7.26 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Systolic Blood Pressure | 2.45 mmHg | Standard Deviation 10.77 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Systolic Blood Pressure | 3.31 mmHg | Standard Deviation 13.2 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Systolic Blood Pressure | 3.67 mmHg | Standard Deviation 12.37 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Mean Arterial Pressure | 2.34 mmHg | Standard Deviation 8.75 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Diastolic Blood Pressure | 0.85 mmHg | Standard Deviation 6.08 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Mean Arterial Pressure | 1.77 mmHg | Standard Deviation 8.81 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Diastolic Blood Pressure | 1.53 mmHg | Standard Deviation 7.09 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Mean Arterial Pressure | 1.38 mmHg | Standard Deviation 7.53 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Diastolic Blood Pressure | 2.65 mmHg | Standard Deviation 9.37 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Mean Arterial Pressure | 3.60 mmHg | Standard Deviation 10.2 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Systolic Blood Pressure | 2.77 mmHg | Standard Deviation 9.04 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Systolic Blood Pressure | 2.33 mmHg | Standard Deviation 8.26 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Diastolic Blood Pressure | 0.36 mmHg | Standard Deviation 4.96 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Mean Arterial Pressure | 1.67 mmHg | Standard Deviation 6.01 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Mean Arterial Pressure | 1.04 mmHg | Standard Deviation 5.34 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Systolic Blood Pressure | 5.59 mmHg | Standard Deviation 16.29 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Diastolic Blood Pressure | 1.11 mmHg | Standard Deviation 4.89 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Diastolic Blood Pressure | -0.50 mmHg | Standard Deviation 6.14 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Systolic Blood Pressure | 2.12 mmHg | Standard Deviation 8.94 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Diastolic Blood Pressure | -0.40 mmHg | Standard Deviation 5.15 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Mean Arterial Pressure | 0.44 mmHg | Standard Deviation 6.23 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Systolic Blood Pressure | -0.21 mmHg | Standard Deviation 11.91 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Diastolic Blood Pressure | -0.21 mmHg | Standard Deviation 6.51 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Mean Arterial Pressure | -0.10 mmHg | Standard Deviation 8.08 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Systolic Blood Pressure | 3.14 mmHg | Standard Deviation 10.02 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Mean Arterial Pressure | 0.70 mmHg | Standard Deviation 6.97 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Systolic Blood Pressure | 0.99 mmHg | Standard Deviation 10.67 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Diastolic Blood Pressure | -0.34 mmHg | Standard Deviation 5.53 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Diastolic Blood Pressure | -0.72 mmHg | Standard Deviation 6.02 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Systolic Blood Pressure | -0.15 mmHg | Standard Deviation 9.3 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Mean Arterial Pressure | -0.35 mmHg | Standard Deviation 6.12 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Systolic Blood Pressure | 0.29 mmHg | Standard Deviation 8.65 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Wake Mean Arterial Pressure | -0.13 mmHg | Standard Deviation 6.65 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Sleep Mean Arterial Pressure | -0.50 mmHg | Standard Deviation 6.22 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | 24-hour Diastolic Blood Pressure | -0.67 mmHg | Standard Deviation 5.24 |
Primary
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis.
Time frame: 6-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 24-hour Systolic Blood Pressure | 2.60 mmHg | Standard Deviation 9.9 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 24-hour Diastolic Blood Pressure | 0.97 mmHg | Standard Deviation 5.5 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 24-hour Mean Arterial Pressure | 1.52 mmHg | Standard Deviation 6.8 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Sleep Systolic Blood Pressure | 4.58 mmHg | Standard Deviation 14.28 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Sleep Diastolic Blood Pressure | 2.07 mmHg | Standard Deviation 8.2 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Sleep Mean Arterial Pressure | 2.94 mmHg | Standard Deviation 9.41 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Wake Systolic Blood Pressure | 2.84 mmHg | Standard Deviation 11.05 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Wake Diastolic Blood Pressure | 0.93 mmHg | Standard Deviation 6.25 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Wake Mean Arterial Pressure | 1.42 mmHg | Standard Deviation 7.31 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Wake Diastolic Blood Pressure | -0.61 mmHg | Standard Deviation 6.04 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Sleep Mean Arterial Pressure | -0.30 mmHg | Standard Deviation 7.19 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 24-hour Diastolic Blood Pressure | -0.53 mmHg | Standard Deviation 5.16 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 24-hour Systolic Blood Pressure | 1.24 mmHg | Standard Deviation 8.78 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | 24-hour Mean Arterial Pressure | 0.06 mmHg | Standard Deviation 6.14 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Wake Systolic Blood Pressure | 2.10 mmHg | Standard Deviation 10.31 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Sleep Systolic Blood Pressure | -0.18 mmHg | Standard Deviation 10.64 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Wake Mean Arterial Pressure | 0.29 mmHg | Standard Deviation 6.78 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Sleep Diastolic Blood Pressure | -0.27 mmHg | Standard Deviation 6.01 |
Primary
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms)
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Systolic Blood Pressure | 1.69 mmHg | Standard Deviation 13.17 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Diastolic Blood Pressure | 0.43 mmHg | Standard Deviation 6.78 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Mean Arterial Pressure | 0.85 mmHg | Standard Deviation 8.81 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Diastolic Blood Pressure | 0.51 mmHg | Standard Deviation 9.08 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Mean Arterial Pressure | 0.93 mmHg | Standard Deviation 11.87 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Systolic Blood Pressure | 1.83 mmHg | Standard Deviation 13.65 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Diastolic Blood Pressure | 0.75 mmHg | Standard Deviation 7.08 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Mean Arterial Pressure | 0.73 mmHg | Standard Deviation 9.04 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Systolic Blood Pressure | 2.1 mmHg | Standard Deviation 17.84 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Diastolic Blood Pressure | 2.1 mmHg | Standard Deviation 8.55 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Diastolic Blood Pressure | 0.77 mmHg | Standard Deviation 5.22 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Systolic Blood Pressure | 1.96 mmHg | Standard Deviation 13.02 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Systolic Blood Pressure | 1.89 mmHg | Standard Deviation 10.18 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Systolic Blood Pressure | 4.81 mmHg | Standard Deviation 15.32 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Diastolic Blood Pressure | 0.24 mmHg | Standard Deviation 4.84 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Mean Arterial Pressure | 1.17 mmHg | Standard Deviation 7.55 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Mean Arterial Pressure | 0.91 mmHg | Standard Deviation 5.9 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Mean Arterial Pressure | 2.89 mmHg | Standard Deviation 9.46 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Mean Arterial Pressure | -0.11 mmHg | Standard Deviation 5.98 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Systolic Blood Pressure | -1.02 mmHg | Standard Deviation 12.08 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Mean Arterial Pressure | -0.15 mmHg | Standard Deviation 7.2 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Diastolic Blood Pressure | -0.88 mmHg | Standard Deviation 6.58 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Mean Arterial Pressure | -0.74 mmHg | Standard Deviation 8.23 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Systolic Blood Pressure | 1.69 mmHg | Standard Deviation 10.64 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Systolic Blood Pressure | 1.30 mmHg | Standard Deviation 8.75 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Diastolic Blood Pressure | -1.06 mmHg | Standard Deviation 6.22 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Diastolic Blood Pressure | -0.82 mmHg | Standard Deviation 4.82 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Diastolic Blood Pressure | -0.83 mmHg | Standard Deviation 5.42 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Systolic Blood Pressure | 0.80 mmHg | Standard Deviation 7.83 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Mean Arterial Pressure | -0.16 mmHg | Standard Deviation 5.61 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Mean Arterial Pressure | 0.02 mmHg | Standard Deviation 6.13 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Systolic Blood Pressure | 0.65 mmHg | Standard Deviation 9.36 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | 24-hour Diastolic Blood Pressure | -0.63 mmHg | Standard Deviation 4.88 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Mean Arterial Pressure | -0.10 mmHg | Standard Deviation 5.63 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Wake Systolic Blood Pressure | 1.14 mmHg | Standard Deviation 9.14 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Sleep Diastolic Blood Pressure | -0.12 mmHg | Standard Deviation 5.27 |
Primary
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | 24-hour Systolic Blood Pressure | 1.82 mmHg | Standard Deviation 13.01 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | 24-hour Diastolic Blood Pressure | 0.59 mmHg | Standard Deviation 6.08 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | 24-hour Mean Arterial Pressure | 1.00 mmHg | Standard Deviation 8.2 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Sleep Systolic Blood Pressure | 3.36 mmHg | Standard Deviation 16.65 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Sleep Diastolic Blood Pressure | 1.25 mmHg | Standard Deviation 8.81 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Sleep Mean Arterial Pressure | 1.84 mmHg | Standard Deviation 10.79 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Wake Systolic Blood Pressure | 1.86 mmHg | Standard Deviation 12.08 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Wake Diastolic Blood Pressure | 0.51 mmHg | Standard Deviation 6.1 |
| Control Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Wake Mean Arterial Pressure | 0.81 mmHg | Standard Deviation 7.69 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Wake Diastolic Blood Pressure | -0.95 mmHg | Standard Deviation 5.79 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Sleep Mean Arterial Pressure | -0.37 mmHg | Standard Deviation 7.24 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | 24-hour Diastolic Blood Pressure | -0.73 mmHg | Standard Deviation 4.81 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | 24-hour Systolic Blood Pressure | 1.06 mmHg | Standard Deviation 8.26 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | 24-hour Mean Arterial Pressure | -0.14 mmHg | Standard Deviation 5.76 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Wake Systolic Blood Pressure | 1.42 mmHg | Standard Deviation 9.86 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Sleep Systolic Blood Pressure | -0.21 mmHg | Standard Deviation 10.79 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Wake Mean Arterial Pressure | -0.13 mmHg | Standard Deviation 6.42 |
| Active Treatment Arms (Pooled) | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Sleep Diastolic Blood Pressure | -0.51 mmHg | Standard Deviation 5.95 |
Comparison: We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint\* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε95% CI: [-5.915, 0.561]
Primary
Difference in CPAP Adherence by Active Treatment Arm
Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization.
Time frame: 6-months
Population: Intent to treat population for those assigned to Active PAP (all individuals who were randomized to one of the two PAP arms).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Difference in CPAP Adherence by Active Treatment Arm | 3.3 hours/night | Standard Deviation 2.7 |
| Active Treatment Arms (Pooled) | Difference in CPAP Adherence by Active Treatment Arm | 4.4 hours/night | Standard Deviation 2.9 |
Comparison: We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).p-value: 0.003Mixed Models Analysis
Secondary
Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm)
Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | -0.9 uIU/mL | Standard Deviation 6.7 |
| Active Treatment Arms (Pooled) | Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | 2.8 uIU/mL | Standard Deviation 12 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | -2.4 uIU/mL | Standard Deviation 15.4 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | 1.1 uIU/mL | Standard Deviation 5.9 |
Secondary
Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm)
Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | 0.1 percentage glycosylated hemoglobin | Standard Deviation 0.4 |
| Active Treatment Arms (Pooled) | Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | -0.2 percentage glycosylated hemoglobin | Standard Deviation 0.6 |
| Active PAP With RT Support (Active-Beh) | Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | -0.04 percentage glycosylated hemoglobin | Standard Deviation 0.5 |
| Active PAP With Behavioral Modification (Active+Beh) | Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | 0.1 percentage glycosylated hemoglobin | Standard Deviation 0.4 |
Secondary
Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm)
The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Component | -1.3 units on a scale | Standard Deviation 7.3 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Component | 0.6 units on a scale | Standard Deviation 7.6 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Vitality Subscale | 0.9 units on a scale | Standard Deviation 14.3 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Functioning | -1.8 units on a scale | Standard Deviation 16.5 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Bodily Pain | -1.7 units on a scale | Standard Deviation 18.8 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 General Health Perceptions | -4.4 units on a scale | Standard Deviation 17.2 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Role Functioning | -2.2 units on a scale | Standard Deviation 21.3 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Emotional Role Functioning | 0 units on a scale | Standard Deviation 20.1 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Social Role Functioning | 1.8 units on a scale | Standard Deviation 17.7 |
| Control Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Health | -0.5 units on a scale | Standard Deviation 13.4 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Vitality Subscale | 5.6 units on a scale | Standard Deviation 11.4 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Social Role Functioning | 0.4 units on a scale | Standard Deviation 14.1 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Functioning | 0.4 units on a scale | Standard Deviation 14.4 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Bodily Pain | -3.4 units on a scale | Standard Deviation 23.2 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 General Health Perceptions | -0.04 units on a scale | Standard Deviation 15.8 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Role Functioning | -0.9 units on a scale | Standard Deviation 22.2 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Health | 1.1 units on a scale | Standard Deviation 9.1 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Emotional Role Functioning | 9.2 units on a scale | Standard Deviation 27.1 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Component | -1.3 units on a scale | Standard Deviation 6.4 |
| Active Treatment Arms (Pooled) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Component | 2.9 units on a scale | Standard Deviation 6.4 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Emotional Role Functioning | 3.7 units on a scale | Standard Deviation 19.5 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Role Functioning | 3.4 units on a scale | Standard Deviation 15.9 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Health | 6.1 units on a scale | Standard Deviation 15.6 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Component | 1.1 units on a scale | Standard Deviation 4.7 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Functioning | 3.3 units on a scale | Standard Deviation 11.2 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 General Health Perceptions | 5.0 units on a scale | Standard Deviation 12.6 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Social Role Functioning | 4.5 units on a scale | Standard Deviation 15.4 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Component | 3.9 units on a scale | Standard Deviation 8.4 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Bodily Pain | 4.1 units on a scale | Standard Deviation 14.4 |
| Active PAP With RT Support (Active-Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Vitality Subscale | 12.7 units on a scale | Standard Deviation 14.9 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Bodily Pain | 7.8 units on a scale | Standard Deviation 19.4 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Emotional Role Functioning | 5.2 units on a scale | Standard Deviation 22.4 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 General Health Perceptions | 7.1 units on a scale | Standard Deviation 14.6 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Health | 1.1 units on a scale | Standard Deviation 11.5 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Role Functioning | -2.11 units on a scale | Standard Deviation 17.3 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Mental Component | 2.2 units on a scale | Standard Deviation 6.3 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Vitality Subscale | 6.4 units on a scale | Standard Deviation 12.6 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Functioning | 3.1 units on a scale | Standard Deviation 13.9 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Physical Component | 1.8 units on a scale | Standard Deviation 4.7 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | SF-36 Social Role Functioning | 3.7 units on a scale | Standard Deviation 14.1 |
Secondary
Change in Augmentation Index at Months 6 and 12 (4 Arms)
Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Augmentation Index at Months 6 and 12 (4 Arms) | -1.2 percent of central pulse pressure | Standard Deviation 9.2 |
| Active Treatment Arms (Pooled) | Change in Augmentation Index at Months 6 and 12 (4 Arms) | -0.4 percent of central pulse pressure | Standard Deviation 8 |
| Active PAP With RT Support (Active-Beh) | Change in Augmentation Index at Months 6 and 12 (4 Arms) | 0.9 percent of central pulse pressure | Standard Deviation 7.5 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Augmentation Index at Months 6 and 12 (4 Arms) | -0.9 percent of central pulse pressure | Standard Deviation 8 |
Secondary
Change in C-Reactive Protein at Months 6 and 12 (4 Arm)
C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP | 0.2 mg/L | Standard Deviation 0.6 |
| Control Arms (Pooled) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP (excluding raw >10) | 0.2 mg/L | Standard Deviation 0.6 |
| Active Treatment Arms (Pooled) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP (excluding raw >10) | 0.1 mg/L | Standard Deviation 0.6 |
| Active Treatment Arms (Pooled) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP | -0.02 mg/L | Standard Deviation 0.8 |
| Active PAP With RT Support (Active-Beh) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP | 0.0003 mg/L | Standard Deviation 0.6 |
| Active PAP With RT Support (Active-Beh) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP (excluding raw >10) | 0.1 mg/L | Standard Deviation 0.5 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP | 0.2 mg/L | Standard Deviation 0.5 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | InCRP (excluding raw >10) | 0.1 mg/L | Standard Deviation 0.5 |
Secondary
Change in Epworth Sleepiness Scale (ESS) (4 Arm)
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Epworth Sleepiness Scale (ESS) (4 Arm) | -0.6 units on a scale | Standard Deviation 3.1 |
| Active Treatment Arms (Pooled) | Change in Epworth Sleepiness Scale (ESS) (4 Arm) | -1.0 units on a scale | Standard Deviation 3.3 |
| Active PAP With RT Support (Active-Beh) | Change in Epworth Sleepiness Scale (ESS) (4 Arm) | -1.9 units on a scale | Standard Deviation 3.1 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Epworth Sleepiness Scale (ESS) (4 Arm) | -1.6 units on a scale | Standard Deviation 4 |
Secondary
Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm)
Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | -0.2 mL/min/1.73m^2 | Standard Deviation 9.9 |
| Active Treatment Arms (Pooled) | Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | 0.6 mL/min/1.73m^2 | Standard Deviation 11 |
| Active PAP With RT Support (Active-Beh) | Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | 0.007 mL/min/1.73m^2 | Standard Deviation 8.3 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | -1.15 mL/min/1.73m^2 | Standard Deviation 9.1 |
Secondary
Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm)
Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Serum Creatinine | -0.007 mg/dL | Standard Deviation 0.1 |
| Control Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Fibrinogen | 18.9 mg/dL | Standard Deviation 56.3 |
| Control Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | B-type Natriuretic Peptide (BNP) | -34.3 mg/dL | Standard Deviation 111.6 |
| Control Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Urine Creatinine | -7.8 mg/dL | Standard Deviation 62.9 |
| Control Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Glucose | 2.9 mg/dL | Standard Deviation 16.2 |
| Active Treatment Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Urine Creatinine | -9.5 mg/dL | Standard Deviation 66.1 |
| Active Treatment Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Serum Creatinine | -0.01 mg/dL | Standard Deviation 0.1 |
| Active Treatment Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | B-type Natriuretic Peptide (BNP) | 4.7 mg/dL | Standard Deviation 138.7 |
| Active Treatment Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Fibrinogen | -2.0 mg/dL | Standard Deviation 72.7 |
| Active Treatment Arms (Pooled) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Glucose | 3.9 mg/dL | Standard Deviation 47.1 |
| Active PAP With RT Support (Active-Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Urine Creatinine | 8.7 mg/dL | Standard Deviation 50.5 |
| Active PAP With RT Support (Active-Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Glucose | 10.9 mg/dL | Standard Deviation 45.9 |
| Active PAP With RT Support (Active-Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Fibrinogen | 2.75 mg/dL | Standard Deviation 45.5 |
| Active PAP With RT Support (Active-Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Serum Creatinine | -0.01 mg/dL | Standard Deviation 0.1 |
| Active PAP With RT Support (Active-Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | B-type Natriuretic Peptide (BNP) | 19.1 mg/dL | Standard Deviation 175.1 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Serum Creatinine | 0.007 mg/dL | Standard Deviation 0.1 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Fibrinogen | 11.9 mg/dL | Standard Deviation 63.8 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Glucose | 1.0 mg/dL | Standard Deviation 12.3 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Urine Creatinine | -5.4 mg/dL | Standard Deviation 41 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | B-type Natriuretic Peptide (BNP) | -3.3 mg/dL | Standard Deviation 68.7 |
Secondary
Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm)
Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | 5.3 pg/dL | Standard Deviation 30.2 |
| Active Treatment Arms (Pooled) | Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | 0.5 pg/dL | Standard Deviation 2.7 |
| Active PAP With RT Support (Active-Beh) | Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | -2.5 pg/dL | Standard Deviation 15.6 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | 0.4 pg/dL | Standard Deviation 2.1 |
Secondary
Change in Lipid Panel at 6 and 12 Months (4 Arm)
Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Lipid measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Total Cholesterol | 5.6 mg/dL | Standard Deviation 19.5 |
| Control Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | VLDL Cholesterol | 0.3 mg/dL | Standard Deviation 5.7 |
| Control Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | HDL Cholesterol | -0.5 mg/dL | Standard Deviation 5.2 |
| Control Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | LDL Cholesterol | 5.1 mg/dL | Standard Deviation 17.5 |
| Control Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Triglycerides | 9.4 mg/dL | Standard Deviation 56.9 |
| Active Treatment Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | LDL Cholesterol | 2.5 mg/dL | Standard Deviation 20.5 |
| Active Treatment Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Total Cholesterol | 4.5 mg/dL | Standard Deviation 27.3 |
| Active Treatment Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | HDL Cholesterol | 1.7 mg/dL | Standard Deviation 6.8 |
| Active Treatment Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Triglycerides | 1.5 mg/dL | Standard Deviation 47.1 |
| Active Treatment Arms (Pooled) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | VLDL Cholesterol | 0.2 mg/dL | Standard Deviation 9.5 |
| Active PAP With RT Support (Active-Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | LDL Cholesterol | 1.4 mg/dL | Standard Deviation 16.5 |
| Active PAP With RT Support (Active-Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Triglycerides | 4.0 mg/dL | Standard Deviation 37.3 |
| Active PAP With RT Support (Active-Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | HDL Cholesterol | -0.7 mg/dL | Standard Deviation 7.8 |
| Active PAP With RT Support (Active-Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Total Cholesterol | 0.7 mg/dL | Standard Deviation 19.5 |
| Active PAP With RT Support (Active-Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | VLDL Cholesterol | 0.1 mg/dL | Standard Deviation 8 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Triglycerides | 1.8 mg/dL | Standard Deviation 28.8 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | VLDL Cholesterol | 0.2 mg/dL | Standard Deviation 5.8 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Total Cholesterol | 6.3 mg/dL | Standard Deviation 20.6 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | LDL Cholesterol | 6.0 mg/dL | Standard Deviation 19 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Lipid Panel at 6 and 12 Months (4 Arm) | HDL Cholesterol | -0.05 mg/dL | Standard Deviation 5.2 |
Secondary
Change in Patient Health Questionnaire (PHQ8) (4 Arm)
The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Patient Health Questionnaire (PHQ8) (4 Arm) | -0.4 units on a scale | Standard Deviation 3.2 |
| Active Treatment Arms (Pooled) | Change in Patient Health Questionnaire (PHQ8) (4 Arm) | -0.9 units on a scale | Standard Deviation 2.5 |
| Active PAP With RT Support (Active-Beh) | Change in Patient Health Questionnaire (PHQ8) (4 Arm) | -1.7 units on a scale | Standard Deviation 3.9 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Patient Health Questionnaire (PHQ8) (4 Arm) | -1.4 units on a scale | Standard Deviation 4 |
Secondary
Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm)
Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | 0.8 AU/mL | Standard Deviation 2.5 |
| Active Treatment Arms (Pooled) | Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | 0.2 AU/mL | Standard Deviation 3.7 |
| Active PAP With RT Support (Active-Beh) | Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | 1.1 AU/mL | Standard Deviation 6.9 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | 0.3 AU/mL | Standard Deviation 4 |
Secondary
Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms)
Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | 0.05 m/s | Standard Deviation 1.9 |
| Active Treatment Arms (Pooled) | Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | -0.03 m/s | Standard Deviation 1.5 |
| Active PAP With RT Support (Active-Beh) | Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | -0.2 m/s | Standard Deviation 2 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | 0.1 m/s | Standard Deviation 1.1 |
Secondary
Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm)
The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | 0.1 units on a scale | Standard Deviation 0.4 |
| Active Treatment Arms (Pooled) | Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | 0.2 units on a scale | Standard Deviation 0.6 |
| Active PAP With RT Support (Active-Beh) | Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | -0.1 units on a scale | Standard Deviation 0.7 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | -0.1 units on a scale | Standard Deviation 0.7 |
Secondary
Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm)
Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | -9.3 ug/mg | Standard Deviation 29.4 |
| Active Treatment Arms (Pooled) | Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | 84.6 ug/mg | Standard Deviation 568 |
| Active PAP With RT Support (Active-Beh) | Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | 1.2 ug/mg | Standard Deviation 55.9 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | 6.0 ug/mg | Standard Deviation 58.8 |
Secondary
Change in Urine Microalbumin at Months 6 and 12 (4 Arm)
Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.
Time frame: Mean of 6- and 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | -16.7 ug/mL | Standard Deviation 31.2 |
| Active Treatment Arms (Pooled) | Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | 45.4 ug/mL | Standard Deviation 315.7 |
| Active PAP With RT Support (Active-Beh) | Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | 3.7 ug/mL | Standard Deviation 43 |
| Active PAP With Behavioral Modification (Active+Beh) | Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | 8.2 ug/mL | Standard Deviation 58.2 |
Secondary
E/Em Lateral Ratio (4 Arm) - 12 Month
Endpoint E/Em Lateral Ratio measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | E/Em Lateral Ratio (4 Arm) - 12 Month | 8.8 mitral velocity ratio (absolute units) | Standard Deviation 3.2 |
| Active Treatment Arms (Pooled) | E/Em Lateral Ratio (4 Arm) - 12 Month | 8.2 mitral velocity ratio (absolute units) | Standard Deviation 2.5 |
| Active PAP With RT Support (Active-Beh) | E/Em Lateral Ratio (4 Arm) - 12 Month | 9.2 mitral velocity ratio (absolute units) | Standard Deviation 2.9 |
| Active PAP With Behavioral Modification (Active+Beh) | E/Em Lateral Ratio (4 Arm) - 12 Month | 8.4 mitral velocity ratio (absolute units) | Standard Deviation 2.8 |
Secondary
E/Em Lateral Ratio (4 Arm) - Baseline
Baseline E/Em Lateral Ratio measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | E/Em Lateral Ratio (4 Arm) - Baseline | 8.6 mitral velocity ratio (absolute units) | Standard Deviation 3.4 |
| Active Treatment Arms (Pooled) | E/Em Lateral Ratio (4 Arm) - Baseline | 8.3 mitral velocity ratio (absolute units) | Standard Deviation 2.7 |
| Active PAP With RT Support (Active-Beh) | E/Em Lateral Ratio (4 Arm) - Baseline | 8.4 mitral velocity ratio (absolute units) | Standard Deviation 2.7 |
| Active PAP With Behavioral Modification (Active+Beh) | E/Em Lateral Ratio (4 Arm) - Baseline | 7.9 mitral velocity ratio (absolute units) | Standard Deviation 2.5 |
Secondary
Ejection Fraction (4 Arm) - 12 Month
Endpoint Ejection Fraction measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Ejection Fraction (4 Arm) - 12 Month | 61.1 percentage ejection fraction | Standard Deviation 4.7 |
| Active Treatment Arms (Pooled) | Ejection Fraction (4 Arm) - 12 Month | 61.4 percentage ejection fraction | Standard Deviation 4.2 |
| Active PAP With RT Support (Active-Beh) | Ejection Fraction (4 Arm) - 12 Month | 60.6 percentage ejection fraction | Standard Deviation 5.1 |
| Active PAP With Behavioral Modification (Active+Beh) | Ejection Fraction (4 Arm) - 12 Month | 60.9 percentage ejection fraction | Standard Deviation 2.7 |
Secondary
Ejection Fraction (4 Arm) - Baseline
Baseline Ejection Fraction measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Ejection Fraction (4 Arm) - Baseline | 60.2 percent ejection fraction | Standard Deviation 4.1 |
| Active Treatment Arms (Pooled) | Ejection Fraction (4 Arm) - Baseline | 60.9 percent ejection fraction | Standard Deviation 2.7 |
| Active PAP With RT Support (Active-Beh) | Ejection Fraction (4 Arm) - Baseline | 60.8 percent ejection fraction | Standard Deviation 6.6 |
| Active PAP With Behavioral Modification (Active+Beh) | Ejection Fraction (4 Arm) - Baseline | 59.9 percent ejection fraction | Standard Deviation 4.6 |
Secondary
End-Diastolic Volume (4 Arm) - 12 Month
Endpoint End-Diastolic Volume measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | End-Diastolic Volume (4 Arm) - 12 Month | 110.7 cm | Standard Deviation 17.4 |
| Active Treatment Arms (Pooled) | End-Diastolic Volume (4 Arm) - 12 Month | 112.3 cm | Standard Deviation 19.6 |
| Active PAP With RT Support (Active-Beh) | End-Diastolic Volume (4 Arm) - 12 Month | 115.5 cm | Standard Deviation 26.9 |
| Active PAP With Behavioral Modification (Active+Beh) | End-Diastolic Volume (4 Arm) - 12 Month | 106.1 cm | Standard Deviation 14 |
Secondary
End-Diastolic Volume (4 Arm) - Baseline
Baseline End-Diastolic Volume measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | End-Diastolic Volume (4 Arm) - Baseline | 113.8 cm | Standard Deviation 18.2 |
| Active Treatment Arms (Pooled) | End-Diastolic Volume (4 Arm) - Baseline | 111.8 cm | Standard Deviation 19.8 |
| Active PAP With RT Support (Active-Beh) | End-Diastolic Volume (4 Arm) - Baseline | 113.4 cm | Standard Deviation 22.8 |
| Active PAP With Behavioral Modification (Active+Beh) | End-Diastolic Volume (4 Arm) - Baseline | 112.3 cm | Standard Deviation 19.7 |
Secondary
Left Atrial (LA) Volume Index (4 Arm) - Baseline
Baseline Left Atrial Mass Index measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Left Atrial (LA) Volume Index (4 Arm) - Baseline | 27.1 m/m2 | Standard Deviation 11 |
| Active Treatment Arms (Pooled) | Left Atrial (LA) Volume Index (4 Arm) - Baseline | 25.3 m/m2 | Standard Deviation 10.6 |
| Active PAP With RT Support (Active-Beh) | Left Atrial (LA) Volume Index (4 Arm) - Baseline | 25.1 m/m2 | Standard Deviation 6.9 |
| Active PAP With Behavioral Modification (Active+Beh) | Left Atrial (LA) Volume Index (4 Arm) - Baseline | 24.2 m/m2 | Standard Deviation 7.7 |
Secondary
Left Atrial Volume Index (4 Arm) - 12 Month
Endpoint Left Atrial Volume Index measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Left Atrial Volume Index (4 Arm) - 12 Month | 25.5 m/m2 | Standard Deviation 11.7 |
| Active Treatment Arms (Pooled) | Left Atrial Volume Index (4 Arm) - 12 Month | 22.3 m/m2 | Standard Deviation 6.7 |
| Active PAP With RT Support (Active-Beh) | Left Atrial Volume Index (4 Arm) - 12 Month | 24.6 m/m2 | Standard Deviation 6.4 |
| Active PAP With Behavioral Modification (Active+Beh) | Left Atrial Volume Index (4 Arm) - 12 Month | 20.7 m/m2 | Standard Deviation 5.6 |
Secondary
Left Ventricular (LV) Mass Index (4 Arm) - Baseline
Baseline Left Ventricular Mass Index measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Left Ventricular (LV) Mass Index (4 Arm) - Baseline | 82.4 g/m2 | Standard Deviation 15.7 |
| Active Treatment Arms (Pooled) | Left Ventricular (LV) Mass Index (4 Arm) - Baseline | 78.5 g/m2 | Standard Deviation 16.4 |
| Active PAP With RT Support (Active-Beh) | Left Ventricular (LV) Mass Index (4 Arm) - Baseline | 77.0 g/m2 | Standard Deviation 19 |
| Active PAP With Behavioral Modification (Active+Beh) | Left Ventricular (LV) Mass Index (4 Arm) - Baseline | 76.3 g/m2 | Standard Deviation 18.9 |
Secondary
Left Ventricular Mass Index (4 Arm) - 12 Month
Endpoint Left Ventricular Mass Index measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Left Ventricular Mass Index (4 Arm) - 12 Month | 82.1 g/m2 | Standard Deviation 17.3 |
| Active Treatment Arms (Pooled) | Left Ventricular Mass Index (4 Arm) - 12 Month | 76.9 g/m2 | Standard Deviation 15.6 |
| Active PAP With RT Support (Active-Beh) | Left Ventricular Mass Index (4 Arm) - 12 Month | 74.2 g/m2 | Standard Deviation 23.7 |
| Active PAP With Behavioral Modification (Active+Beh) | Left Ventricular Mass Index (4 Arm) - 12 Month | 70.4 g/m2 | Standard Deviation 18 |
Secondary
Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month
12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 235.4 cm/sec | Standard Deviation 32.9 |
| Active Treatment Arms (Pooled) | Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 253.1 cm/sec | Standard Deviation 35 |
| Active PAP With RT Support (Active-Beh) | Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 232.0 cm/sec | Standard Deviation 13.6 |
| Active PAP With Behavioral Modification (Active+Beh) | Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 254.7 cm/sec | Standard Deviation 23.3 |
Secondary
Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline
Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | 243.5 cm/sec | Standard Deviation 22.1 |
| Active Treatment Arms (Pooled) | Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | 240.4 cm/sec | Standard Deviation 23.9 |
| Active PAP With RT Support (Active-Beh) | Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | 244.0 cm/sec | Standard Deviation 21.3 |
| Active PAP With Behavioral Modification (Active+Beh) | Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | 248.3 cm/sec | Standard Deviation 30.7 |
Secondary
Pulmonary Vascular Resistance (4 Arm) - 12 Month
Endpoint Pulmonary Vascular Resistance measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Pulmonary Vascular Resistance (4 Arm) - 12 Month | 148.4 Wood units | Standard Deviation 26.7 |
| Active Treatment Arms (Pooled) | Pulmonary Vascular Resistance (4 Arm) - 12 Month | 138.2 Wood units | Standard Deviation 16.6 |
| Active PAP With RT Support (Active-Beh) | Pulmonary Vascular Resistance (4 Arm) - 12 Month | 144.0 Wood units | Standard Deviation 54.8 |
| Active PAP With Behavioral Modification (Active+Beh) | Pulmonary Vascular Resistance (4 Arm) - 12 Month | 131.3 Wood units | Standard Deviation 29.1 |
Secondary
Pulmonary Vascular Resistance (4 Arm) - Baseline
Baseline Pulmonary Vascular Resistance measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Pulmonary Vascular Resistance (4 Arm) - Baseline | 154.6 Wood units | Standard Deviation 30.1 |
| Active Treatment Arms (Pooled) | Pulmonary Vascular Resistance (4 Arm) - Baseline | 135.5 Wood units | Standard Deviation 40.3 |
| Active PAP With RT Support (Active-Beh) | Pulmonary Vascular Resistance (4 Arm) - Baseline | 151.1 Wood units | Standard Deviation 35.2 |
| Active PAP With Behavioral Modification (Active+Beh) | Pulmonary Vascular Resistance (4 Arm) - Baseline | 157.0 Wood units | Standard Deviation 39.1 |
Secondary
Right Ventricular Fractional Area Change (4 Arm) - 12 Month
Endpoint Right Ventricular Fractional Area Change measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Right Ventricular Fractional Area Change (4 Arm) - 12 Month | 0.5 percentage change in RV area | Standard Deviation 0 |
| Active Treatment Arms (Pooled) | Right Ventricular Fractional Area Change (4 Arm) - 12 Month | 0.5 percentage change in RV area | Standard Deviation 0 |
| Active PAP With RT Support (Active-Beh) | Right Ventricular Fractional Area Change (4 Arm) - 12 Month | 0.5 percentage change in RV area | Standard Deviation 0 |
| Active PAP With Behavioral Modification (Active+Beh) | Right Ventricular Fractional Area Change (4 Arm) - 12 Month | 0.5 percentage change in RV area | Standard Deviation 0 |
Secondary
Right Ventricular Fractional Area Change (4 Arm) - Baseline
Baseline RV Fractional Area Change measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Right Ventricular Fractional Area Change (4 Arm) - Baseline | 0.5 percentage change in RV area | Standard Deviation 0.1 |
| Active Treatment Arms (Pooled) | Right Ventricular Fractional Area Change (4 Arm) - Baseline | 0.5 percentage change in RV area | Standard Deviation 0 |
| Active PAP With RT Support (Active-Beh) | Right Ventricular Fractional Area Change (4 Arm) - Baseline | 0.5 percentage change in RV area | Standard Deviation 0.1 |
| Active PAP With Behavioral Modification (Active+Beh) | Right Ventricular Fractional Area Change (4 Arm) - Baseline | 0.5 percentage change in RV area | Standard Deviation 0 |
Secondary
Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month
Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | 14.1 cm/sec | Standard Deviation 3.6 |
| Active Treatment Arms (Pooled) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | 13.5 cm/sec | Standard Deviation 2.5 |
| Active PAP With RT Support (Active-Beh) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | 13.6 cm/sec | Standard Deviation 2.5 |
| Active PAP With Behavioral Modification (Active+Beh) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | 14.1 cm/sec | Standard Deviation 2.5 |
Secondary
Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline
Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.
Time frame: 12-months
Population: Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arms (Pooled) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | 14.2 cm/sec | Standard Deviation 3.5 |
| Active Treatment Arms (Pooled) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | 13.1 cm/sec | Standard Deviation 3 |
| Active PAP With RT Support (Active-Beh) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | 13.5 cm/sec | Standard Deviation 2.4 |
| Active PAP With Behavioral Modification (Active+Beh) | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | 13.1 cm/sec | Standard Deviation 3.1 |