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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP + Peer Support | Active Comparator | Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study. All participants will receive CPAP in addition to this intervention. |
|
| CPAP + Individual Education | Active Comparator | Participants randomized to this arm will receive individual support and education from a trained investigator. All participants will receive CPAP in addition to this intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP + Peer Support | Behavioral |
| ||
| CPAP + Individual Education |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Objective adherence to CPAP, measured in hours per night. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adherence >=4 Hours/Night on Average | Objective adherence to CPAP, percentage with adherence >=4 hours/night on average | 6 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Redline, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Individual Education | Participants randomized to this arm will receive individual support and education from a trained investigator. Individual Education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Individual Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence | Objective adherence to CPAP, measured in hours per night. | Posted | Mean | Standard Deviation | hours/night | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peer Support | Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study. Peer Support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessie Bakker | Brigham and Women's Hospital | 617-732-5987 | jpbakker@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Behavioral |
|
| 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
Participants randomized to this arm will receive individual support and education from a trained investigator. Individual Education |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Underwent home sleep testing (as opposed to in-lab sleep testing) | Count of Participants | Participants |
|
| Apnea-hypopnea index | The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and >= 30 events/h = severe | Median | Inter-Quartile Range | Events/hour |
|
| Oxygen saturation nadir | Median | Inter-Quartile Range | % of oxygen saturation |
|
| Pressure 95th percentile | The 95th percentile CPAP pressure is the pressure at or below which the patient spent 95% of the time that night. | Two participants (intervention arm) missing data for 95th percentile pressure due to CPAP data-card error. | Median | Inter-Quartile Range | cmH2O |
|
| Leak 95th percentile | The 95th percentile leak is the leak level (liters/minute) at or below which the patient spent 95% of the time that night | Two participants (intervention arm) missing data for 95th percentile leak due to CPAP data-card error. | Median | Inter-Quartile Range | liters/minute |
|
| Residual apnea-hypopnea index | The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and >= 30 events/h = severe | Two participants (intervention arm) missing data for residual AHI due to CPAP data-card error. | Median | Inter-Quartile Range | events/hour |
|
| Functional Outcomes of Sleep Questionnaire | The Functional Outcomes of Sleep Questionnaire is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep. | Mean | Standard Deviation | units on a scale |
|
| Self Efficacy Measure for Sleep Apnea - Perceived Risk | The Self Efficacy Measure for Seep Apnea 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. | Mean | Standard Deviation | units on a scale |
|
| Self Efficacy Measure for Sleep Apnea - Outcome Expectations | The Self Efficacy Measure for Seep Apnea 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. | Mean | Standard Deviation | units on a scale |
|
| Self Efficacy Measure for Sleep Apnea - Self Efficacy | The Self Efficacy Measure for Seep Apnea 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. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Percentage of Participants With Adherence >=4 Hours/Night on Average | Objective adherence to CPAP, percentage with adherence >=4 hours/night on average | Posted | Number | percentage of participants | 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Individual Education | Participants randomized to this arm will receive individual support and education from a trained investigator. Individual Education | 0 | 20 | 0 | 20 | 0 | 20 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|