Sleep Apnea, Obstructive
Conditions
Brief summary
The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education.
Detailed description
The study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). Participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning CPAP and the other occurring two weeks later. Participants in the individual education (comparator) arm will begin CPAP without attendance at any peer-support sessions.
Interventions
BEHAVIORALCPAP + Peer Support
BEHAVIORALCPAP + Individual Education
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with obstructive sleep apnea (no cut-off for severity) * Prescribed continuous positive airway pressure
Exclusion criteria
* Not fluent in English * Prior CPAP use at home * Current use of any non-CPAP treatment for obstructive sleep apnea * A co-morbid sleep disorder * Use of supplemental oxygen * A clinical need for urgent CPAP therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 weeks | Objective adherence to CPAP, measured in hours per night. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adherence >=4 Hours/Night on Average | 6 weeks | Objective adherence to CPAP, percentage with adherence \>=4 hours/night on average |
| FOSQ | 6 weeks | Functional Outcomes of Sleep Questionnaire. The FOSQ is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep. |
| SEMSA - Perceived Risk | 6 weeks | Self Efficacy Measure for Sleep Apnea - Perceived Risk The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of perceived risk associated with sleep apnea. |
| SEMSA - Outcome Expectations | 6 weeks | Self Efficacy Measure for Sleep Apnea - Outcome Expectations. The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of outcome expectations associated with treatment of sleep apnea. |
| SEMSA - Self Efficacy | 6 weeks | Self Efficacy Measure for Sleep Apnea - Self Efficacy The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of self efficacy associated with treatment of sleep apnea. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peer Support Participants randomized to this arm will receive support from a 'Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.
Peer Support | 20 |
| Individual Education Participants randomized to this arm will receive individual support and education from a trained investigator.
Individual Education | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Peer Support | Individual Education | Total |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 13.3 | 50.4 years STANDARD_DEVIATION 13.5 | 49.9 years STANDARD_DEVIATION 13.2 |
| Apnea-hypopnea index | 11.1 Events/hour | 14.3 Events/hour | 11.4 Events/hour |
| Body mass index | 32.3 kg/m^2 STANDARD_DEVIATION 5.3 | 30.3 kg/m^2 STANDARD_DEVIATION 5.8 | 31.3 kg/m^2 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 20 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Functional Outcomes of Sleep Questionnaire | 16.2 units on a scale STANDARD_DEVIATION 2.3 | 14.1 units on a scale STANDARD_DEVIATION 3.3 | 15.2 units on a scale STANDARD_DEVIATION 3 |
| Leak 95th percentile | 17.7 liters/minute | 17.9 liters/minute | 17.7 liters/minute |
| Oxygen saturation nadir | 81.5 % of oxygen saturation | 83.0 % of oxygen saturation | 82.5 % of oxygen saturation |
| Pressure 95th percentile | 11.4 cmH2O | 10.7 cmH2O | 10.9 cmH2O |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 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 | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 15 Participants | 32 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Residual apnea-hypopnea index | 2.6 events/hour | 2.3 events/hour | 2.6 events/hour |
| Self Efficacy Measure for Sleep Apnea - Outcome Expectations | 2.0 units on a scale STANDARD_DEVIATION 0.4 | 2.1 units on a scale STANDARD_DEVIATION 0.6 | 2.0 units on a scale STANDARD_DEVIATION 0.5 |
| Self Efficacy Measure for Sleep Apnea - Perceived Risk | 1.5 units on a scale STANDARD_DEVIATION 0.4 | 1.7 units on a scale STANDARD_DEVIATION 0.4 | 1.6 units on a scale STANDARD_DEVIATION 0.4 |
| Self Efficacy Measure for Sleep Apnea - Self Efficacy | 2.1 units on a scale STANDARD_DEVIATION 0.5 | 2.1 units on a scale STANDARD_DEVIATION 0.6 | 2.1 units on a scale STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
| Underwent home sleep testing (as opposed to in-lab sleep testing) | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Adherence
Objective adherence to CPAP, measured in hours per night.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Support | Adherence | 4.5 hours/night | Standard Deviation 2.1 |
| Individual Education | Adherence | 5.0 hours/night | Standard Deviation 2.2 |
Secondary
FOSQ
Functional Outcomes of Sleep Questionnaire. The FOSQ is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Support | FOSQ | 17.7 units on a scale | Standard Deviation 1.3 |
| Individual Education | FOSQ | 16.1 units on a scale | Standard Deviation 2.8 |
Secondary
Percentage of Participants With Adherence >=4 Hours/Night on Average
Objective adherence to CPAP, percentage with adherence \>=4 hours/night on average
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peer Support | Percentage of Participants With Adherence >=4 Hours/Night on Average | 65 percentage of participants |
| Individual Education | Percentage of Participants With Adherence >=4 Hours/Night on Average | 65 percentage of participants |
Secondary
SEMSA - Outcome Expectations
Self Efficacy Measure for Sleep Apnea - Outcome Expectations. The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of outcome expectations associated with treatment of sleep apnea.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Support | SEMSA - Outcome Expectations | 2.2 units on a scale | Standard Deviation 0.8 |
| Individual Education | SEMSA - Outcome Expectations | 2.3 units on a scale | Standard Deviation 0.6 |
Secondary
SEMSA - Perceived Risk
Self Efficacy Measure for Sleep Apnea - Perceived Risk The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of perceived risk associated with sleep apnea.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Support | SEMSA - Perceived Risk | 1.6 units on a scale | Standard Deviation 0.7 |
| Individual Education | SEMSA - Perceived Risk | 1.7 units on a scale | Standard Deviation 0.6 |
Secondary
SEMSA - Self Efficacy
Self Efficacy Measure for Sleep Apnea - Self Efficacy The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of self efficacy associated with treatment of sleep apnea.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Support | SEMSA - Self Efficacy | 2.2 units on a scale | Standard Deviation 0.8 |
| Individual Education | SEMSA - Self Efficacy | 2.3 units on a scale | Standard Deviation 0.6 |