Stroke, Transient Ischemic Attack
Conditions
Keywords
Sleep Apnea, CPAP adherence, behavioral adherence, stroke
Brief summary
The goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(PAP) therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. Therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.
Detailed description
The proposed study is a randomized controlled trial among patients with transient ischemic attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly assigned to either usual care or a diagnosis and treatment approach that includes ambulatory polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2 (control:intervention) randomization scheme. Intervention patients with sleep apnea will receive either a standard CPAP treatment intervention or an enhanced protocol designed to increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP on pathophysiologic markers in the following domains of cardiovascular risk: inflammation (CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C), endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media thickness); and (b) long-term (6-12 month) CPAP adherence.
Interventions
DEVICEStandard CPAP Intervention
BEHAVIORALEnhanced CPAP Intervention
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Indiana University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * TIA or ischemic stroke * within 1 week of neurological symptom onset * brain imaging within 24 hours
Exclusion criteria
* known to have sleep apnea * suspected sleep disorder other than sleep apnea * hospice patients or patients receiving comfort only measures * patients unable to use a nasal or face mask * patients who require mechanical ventilation * Non English language patients * inability to provide informed consent * active suicidal ideation * live outside the recruitment area * provider does not allow researcher to contact patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Adherence Rates Change From Baseline | Baseline to up to 12 months | CPAP adherence rates were calculated as hours of CPAP use per night. The change from baseline up until the final measurement (up to 12 months) was assessed. The Respironics M-series (now System One, Phillips Respironics, North Ryde, Australia) produced a record of the patient adherence (hours of use per night) throughout the duration of the follow up period. |
| HOMA IR Change From Baseline | Baseline and up to 12 months | The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.). The change from baseline up until the final measurement (up to 12 months) was assessed. |
| CRP Change From Baseline | Baseline and up to 12 months | C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| IL-6 Change From Baseline | Baseline and up to 12 months | IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. Il-6 is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Catecholamine Change From Baseline | Baseline and up to 12 months | Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamine is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Heart Rate Variability Change From Baseline | Baseline and up to 12 months | Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| 24-H Systolic Blood Pressure Mean Change From Baseline | Baseline and up to 12 months | 24-H Systolic Blood Pressure is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Flow-mediated Vasodilation Mean Change From Baseline | Baseline to up to 12 months | Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Carotid Intima-Medial Thickness Mean Change From Baseline | Baseline to up to 12 months | Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness mean change is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOMA IR Change From Baseline With CPAP Use | Baseline to up to 12 months | The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.) To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| CRP Change From Baseline With CPAP Use | Baseline to up to 12 months | C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| IL-6 Change From Baseline With CPAP Use | Baseline to up to 12 months | IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. IL-6 is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Catecholamine Change From Baseline With CPAP Use | Baseline to up to 12 months | Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamines change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Heart Rate Variability Change From Baseline With CPAP Use | Baseline to up to 12 months | Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use | Baseline to up to 12 months | 24-H Mean Systolic Blood Pressure change is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use | Baseline to up to 12 months | Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change | Baseline to up to 12 months | Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. The carotid intimal thickness measurement was obtained by averaging the distance between the lumen-intima interface and the media-adventitia interface obtained from 5 contiguous sites 1 mm apart. |
| Medication-adjusted 24-H SBP Change From Baseline | Baseline to up to 12 months | Change in medication-adjusted 24-hour SBP, which is calculated as \[mean 24-hour SBP in mmHg\] + \[patient's DDD × (8.0 mmHg), was assessed between CPAP adherence groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
Countries
United States
Participant flow
Pre-assignment details
Three patients withdrew prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Standard Intervention Group This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.
Standard CPAP Intervention | 86 |
| Enhanced CPAP Intervention This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.
Enhanced CPAP Intervention | 82 |
| Usual Care This group usual care after TIA/stroke and a sleep study at the end of the study. | 84 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 | 3 |
| Overall Study | Physician Decision | 0 | 0 | 2 |
| Overall Study | Significant illness | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 5 |
Baseline characteristics
| Characteristic | Enhanced CPAP Intervention | Usual Care | Standard Intervention Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 23 Participants | 26 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 61 Participants | 60 Participants | 180 Participants |
| Age, Continuous | 61.3 years STANDARD_DEVIATION 12.8 | 60.3 years STANDARD_DEVIATION 12.5 | 60.0 years STANDARD_DEVIATION 12.5 | 60.5 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 82 participants | 84 participants | 86 participants | 252 participants |
| Sex: Female, Male Female | 37 Participants | 42 Participants | 42 Participants | 121 Participants |
| Sex: Female, Male Male | 45 Participants | 42 Participants | 44 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 4 / 82 | 2 / 84 |
| other Total, other adverse events | 2 / 86 | 3 / 82 | 3 / 84 |
| serious Total, serious adverse events | 3 / 86 | 6 / 82 | 7 / 84 |
Outcome results
Primary
24-H Systolic Blood Pressure Mean Change From Baseline
24-H Systolic Blood Pressure is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline and up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | 24-H Systolic Blood Pressure Mean Change From Baseline | 0.6 mmHg | Standard Deviation 12.8 |
| Enhanced CPAP Intervention | 24-H Systolic Blood Pressure Mean Change From Baseline | -1.2 mmHg | Standard Deviation 12.5 |
| Usual Care | 24-H Systolic Blood Pressure Mean Change From Baseline | 5.9 mmHg | Standard Deviation 13.4 |
Primary
Carotid Intima-Medial Thickness Mean Change From Baseline
Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness mean change is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Carotid Intima-Medial Thickness Mean Change From Baseline | 0.0 mm | Standard Deviation 0.1 |
| Enhanced CPAP Intervention | Carotid Intima-Medial Thickness Mean Change From Baseline | 0.0 mm | Standard Deviation 0.1 |
| Usual Care | Carotid Intima-Medial Thickness Mean Change From Baseline | 0.0 mm | Standard Deviation 0.1 |
Primary
Catecholamine Change From Baseline
Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamine is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline and up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Catecholamine Change From Baseline | 192.4 pg/ml | Standard Deviation 385 |
| Enhanced CPAP Intervention | Catecholamine Change From Baseline | 5.8 pg/ml | Standard Deviation 259.6 |
| Usual Care | Catecholamine Change From Baseline | 89.0 pg/ml | Standard Deviation 231.8 |
Primary
CPAP Adherence Rates Change From Baseline
CPAP adherence rates were calculated as hours of CPAP use per night. The change from baseline up until the final measurement (up to 12 months) was assessed. The Respironics M-series (now System One, Phillips Respironics, North Ryde, Australia) produced a record of the patient adherence (hours of use per night) throughout the duration of the follow up period.
Time frame: Baseline to up to 12 months
Population: The analysis population is a subset of patients in the standard and enhanced intervention arms that had a diagnosis of sleep apnea.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | CPAP Adherence Rates Change From Baseline | 3.9 Hours per night | Standard Deviation 2.1 |
| Enhanced CPAP Intervention | CPAP Adherence Rates Change From Baseline | 4.3 Hours per night | Standard Deviation 2.4 |
Primary
CRP Change From Baseline
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline and up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | CRP Change From Baseline | 0.8 mg/dl | Standard Deviation 14.4 |
| Enhanced CPAP Intervention | CRP Change From Baseline | 0.9 mg/dl | Standard Deviation 10.2 |
| Usual Care | CRP Change From Baseline | -3.0 mg/dl | Standard Deviation 13 |
Primary
Flow-mediated Vasodilation Mean Change From Baseline
Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Flow-mediated Vasodilation Mean Change From Baseline | 1.0 mm | Standard Deviation 3 |
| Enhanced CPAP Intervention | Flow-mediated Vasodilation Mean Change From Baseline | 0.1 mm | Standard Deviation 2.2 |
| Usual Care | Flow-mediated Vasodilation Mean Change From Baseline | -0.3 mm | Standard Deviation 2.9 |
Primary
Heart Rate Variability Change From Baseline
Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline and up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Heart Rate Variability Change From Baseline | -8.0 milliseconds | Standard Deviation 20 |
| Enhanced CPAP Intervention | Heart Rate Variability Change From Baseline | 5.0 milliseconds | Standard Deviation 30.5 |
| Usual Care | Heart Rate Variability Change From Baseline | -1.5 milliseconds | Standard Deviation 26.4 |
Primary
HOMA IR Change From Baseline
The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.). The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline and up to 12 months
Population: Intention to treat analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | HOMA IR Change From Baseline | 0.9 HOMA-IR Index | Standard Deviation 3 |
| Enhanced CPAP Intervention | HOMA IR Change From Baseline | 4.0 HOMA-IR Index | Standard Deviation 12.7 |
| Usual Care | HOMA IR Change From Baseline | 4.1 HOMA-IR Index | Standard Deviation 24.8 |
Primary
IL-6 Change From Baseline
IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. Il-6 is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline and up to 12 months
Population: Intention to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | IL-6 Change From Baseline | 4.0 pg/ml | Standard Deviation 11 |
| Enhanced CPAP Intervention | IL-6 Change From Baseline | 1.8 pg/ml | Standard Deviation 40.6 |
| Usual Care | IL-6 Change From Baseline | -0.7 pg/ml | Standard Deviation 3.9 |
Secondary
24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use
24-H Mean Systolic Blood Pressure change is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use | 3.8 mmHg | Standard Deviation 11.1 |
| Enhanced CPAP Intervention | 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use | -4.9 mmHg | Standard Deviation 15 |
| Usual Care | 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use | 0.1 mmHg | Standard Deviation 10.3 |
Secondary
Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change
Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. The carotid intimal thickness measurement was obtained by averaging the distance between the lumen-intima interface and the media-adventitia interface obtained from 5 contiguous sites 1 mm apart.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change | 0.0 mm | Standard Deviation 0.1 |
| Enhanced CPAP Intervention | Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change | 0.0 mm | Standard Deviation 0.1 |
| Usual Care | Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change | 0.0 mm | Standard Deviation 0.1 |
Secondary
Catecholamine Change From Baseline With CPAP Use
Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamines change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Catecholamine Change From Baseline With CPAP Use | 76.7 pg/ml | Standard Deviation 245.5 |
| Enhanced CPAP Intervention | Catecholamine Change From Baseline With CPAP Use | -27.8 pg/ml | Standard Deviation 288.2 |
| Usual Care | Catecholamine Change From Baseline With CPAP Use | 184 pg/ml | Standard Deviation 436.6 |
Secondary
CRP Change From Baseline With CPAP Use
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | CRP Change From Baseline With CPAP Use | 0.8 mg/dl | Standard Deviation 14.4 |
| Enhanced CPAP Intervention | CRP Change From Baseline With CPAP Use | 0.9 mg/dl | Standard Deviation 10.2 |
| Usual Care | CRP Change From Baseline With CPAP Use | -3.0 mg/dl | Standard Deviation 13 |
Secondary
Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use
Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use | -0.7 mm | Standard Deviation 3.2 |
| Enhanced CPAP Intervention | Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use | 2.7 mm | Standard Deviation 3.1 |
| Usual Care | Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use | 0.3 mm | Standard Deviation 2.1 |
Secondary
Heart Rate Variability Change From Baseline With CPAP Use
Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Heart Rate Variability Change From Baseline With CPAP Use | 3.2 milliseconds | Standard Deviation 18.9 |
| Enhanced CPAP Intervention | Heart Rate Variability Change From Baseline With CPAP Use | -5.4 milliseconds | Standard Deviation 24.8 |
| Usual Care | Heart Rate Variability Change From Baseline With CPAP Use | 5.3 milliseconds | Standard Deviation 33.5 |
Secondary
HOMA IR Change From Baseline With CPAP Use
The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.) To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | HOMA IR Change From Baseline With CPAP Use | -0.2 HOMA-IR Index | Standard Deviation 1 |
| Enhanced CPAP Intervention | HOMA IR Change From Baseline With CPAP Use | 2.4 HOMA-IR Index | Standard Deviation 12 |
| Usual Care | HOMA IR Change From Baseline With CPAP Use | 3.3 HOMA-IR Index | Standard Deviation 9.7 |
Secondary
IL-6 Change From Baseline With CPAP Use
IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. IL-6 is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | IL-6 Change From Baseline With CPAP Use | -5.3 pg/ml | Standard Deviation 27.3 |
| Enhanced CPAP Intervention | IL-6 Change From Baseline With CPAP Use | 3.3 pg/ml | Standard Deviation 11.5 |
| Usual Care | IL-6 Change From Baseline With CPAP Use | 11.9 pg/ml | Standard Deviation 41.7 |
Secondary
Medication-adjusted 24-H SBP Change From Baseline
Change in medication-adjusted 24-hour SBP, which is calculated as \[mean 24-hour SBP in mmHg\] + \[patient's DDD × (8.0 mmHg), was assessed between CPAP adherence groups. The change from baseline up until the final measurement (up to 12 months) was assessed.
Time frame: Baseline to up to 12 months
Population: The analysis population comprises of those with a sleep apnea diagnosis and is split into 3 categories of CPAP use where the treatment arms are combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Intervention Group | Medication-adjusted 24-H SBP Change From Baseline | 7.8 mmHg | Standard Deviation 13.9 |
| Enhanced CPAP Intervention | Medication-adjusted 24-H SBP Change From Baseline | 5.3 mmHg | Standard Deviation 17.3 |
| Usual Care | Medication-adjusted 24-H SBP Change From Baseline | 0.1 mmHg | Standard Deviation 12.3 |