Obstructive Sleep Apnea
Conditions
Keywords
sleep apnea, positive airway pressure, portable monitoring, auto positive airway pressure
Brief summary
The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.
Detailed description
RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways. METHODS: Study visits: Before informed consent (routine clinical care) 1. Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires. 2. Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria After informed consent 1. PM study 2. Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the patient will be offered a diagnostic PSG. If this is positive, they will have APAP treatment. If both the PM and PSG are negative for OSA the patient exits the study but will be followed in sleep clinic. 3. PSG for CPAP titration (PSG arm only). 4. CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory therapist will setup the units, fit masks, and instruct the patients on the use of their device. Patients being treated with CPAP or APAP will be in separate classes. 5. Telephone contact within 7 days of setup with early intervention for PAP problems if needed. 6. Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ, and PAP satisfaction questionnaire.
Interventions
DEVICEContinuous positive airway pressure
continuous positive airway pressure determined by polysomnography titration
DEVICEAuto-adjusting positive airway pressure treatment
Pressure range 4-18 centimeters of water (cm H2O)
Sponsors
North Florida Foundation for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* OSA, Apnea-hypopnea index \> 5/hour
Exclusion criteria
* Prior CPAP * Uncontrolled Depression * Moderate to Severe chronic obstructive pulmonary disease (COPD) * Hypoventilation * Average estimated nightly total sleep time \< 4 hours * Shift work * Unstable depression * Upper airway surgery * Uncontrolled Restless legs syndrome (RLS), narcolepsy * Use of supplemental oxygen * Severe congestive heart failure * Use of nightly potent narcotics * Severe obesity (BMI \> 40)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Airway Pressure Adherence (Nightly Use of Treatment) | 6 weeks after starting treatment | average nightly hours of using positive airway pressure (including 0 for nights not used) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Epworth Sleepiness Scale | 6 weeks after starting treatment | Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness. |
| Change in Functional Outcomes of Sleep Questionnaire | 6 weeks at clinic | The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life. |
| Residual Apnea-hypopnea Index | over first 6 weeks of treatment | The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI \< 10 is considered adequate treatment and \<5/hour ideal treatment. |
| Treatment Pressure (Level of CPAP or 90th Percentile APAP) | 6 weeks clinic | The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PSG CPAP Titration Then CPAP Treatment Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration | 78 |
| Auto-Adjusting Positive Airway Pressure Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O) | 78 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 9 |
| Overall Study | not using CPAP | 5 | 3 |
| Overall Study | Withdrawal by Subject | 8 | 0 |
Baseline characteristics
| Characteristic | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.9 | 58.3 years STANDARD_DEVIATION 12 | 58.7 years STANDARD_DEVIATION 12.4 |
| apnea+hypopnea index | 31.0 number of apneas and hypopneas /hour STANDARD_DEVIATION 19.1 | 28.6 number of apneas and hypopneas /hour STANDARD_DEVIATION 18.2 | 29.8 number of apneas and hypopneas /hour STANDARD_DEVIATION 18.6 |
| Body mass index | 34.9 kg/m^2 STANDARD_DEVIATION 6 | 34.2 kg/m^2 STANDARD_DEVIATION 5.8 | 34.6 kg/m^2 STANDARD_DEVIATION 5.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 22 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 56 Participants | 115 Participants |
| Region of Enrollment United States | 78 participants | 78 participants | 156 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 72 Participants | 73 Participants | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 78 | 12 / 78 |
| serious Total, serious adverse events | 0 / 78 | 0 / 78 |
Outcome results
Primary
Positive Airway Pressure Adherence (Nightly Use of Treatment)
average nightly hours of using positive airway pressure (including 0 for nights not used)
Time frame: 6 weeks after starting treatment
Population: patients using cpap or apap at clinic visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | Positive Airway Pressure Adherence (Nightly Use of Treatment) | 3.99 hours | Standard Deviation 2.3 |
| Auto-Adjusting Positive Airway Pressure | Positive Airway Pressure Adherence (Nightly Use of Treatment) | 4.45 hours | Standard Deviation 2.3 |
p-value: =0.2795% CI: [-0.35, 1.26]t-test, 2 sided
Secondary
Change in Epworth Sleepiness Scale
Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.
Time frame: 6 weeks after starting treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | Change in Epworth Sleepiness Scale | -3.7 units on a scale | Standard Deviation 4.8 |
| Auto-Adjusting Positive Airway Pressure | Change in Epworth Sleepiness Scale | -4.1 units on a scale | Standard Deviation 4.7 |
Comparison: Patients using PAP (average of \>=1/2 hour per night) at 6 weeks clinic visitp-value: =0.6595% CI: [-1.3, 2.1]t-test, 2 sided
Secondary
Change in Functional Outcomes of Sleep Questionnaire
The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.
Time frame: 6 weeks at clinic
Population: Using PAP 1/2 hour or more nightly
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | Change in Functional Outcomes of Sleep Questionnaire | 2.2 units on a scale | Standard Deviation 3.7 |
| Auto-Adjusting Positive Airway Pressure | Change in Functional Outcomes of Sleep Questionnaire | 2.6 units on a scale | Standard Deviation 3.5 |
Comparison: Patients using PAP (average \>=1/2 hour per nightly use) at 6 weeks clinic visitp-value: =0.3395% CI: [-0.73, 2.1]t-test, 2 sided
Secondary
Residual Apnea-hypopnea Index
The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI \< 10 is considered adequate treatment and \<5/hour ideal treatment.
Time frame: over first 6 weeks of treatment
Population: participants using PAP at clinic visit (\>= 1/2 hour of nightly use)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | Residual Apnea-hypopnea Index | 4.9 events (apneas+hypopneas)/hour | Standard Deviation 4.9 |
| Auto-Adjusting Positive Airway Pressure | Residual Apnea-hypopnea Index | 5.5 events (apneas+hypopneas)/hour | Standard Deviation 4.7 |
Comparison: Patients using PAP (average \>= 1/2 hour of nightly use) at 6 weeks clinic visitp-value: =0.4995% CI: [-1.12, 2.29]t-test, 2 sided
Secondary
Treatment Pressure (Level of CPAP or 90th Percentile APAP)
The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.
Time frame: 6 weeks clinic
Population: participants using PAP at the 6 weeks clinic visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | Treatment Pressure (Level of CPAP or 90th Percentile APAP) | 11.7 cm H2O | Standard Deviation 2.5 |
| Auto-Adjusting Positive Airway Pressure | Treatment Pressure (Level of CPAP or 90th Percentile APAP) | 10.8 cm H2O | Standard Deviation 3.1 |
Comparison: participants using PAP (average \>=1/2 hour of use) at 6 weeks clinic visitp-value: =0.0795% CI: [-1.92, 0.09]t-test, 2 sided