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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL169588 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Pittsburgh | OTHER |
| MetroHealth System, Ohio | OTHER |
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The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.
This is a multiple site randomized controlled trial of 220 African American patients diagnosed with moderate to severe OSA and their bed partners. Half of the patients will receive optimal usual care, consisting of sleep therapist-initiated CPAP education and training. Patients will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of optimal usual care. Couples will participate in couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Placebo Comparator | Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual. |
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| Couple-oriented Intervention Arm | Active Comparator | Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following
5. 5 cognitive behavioral couple therapy sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP Training and Education | Behavioral | Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Nightly CPAP Use at 1 Year | Mean CPAP use at year will be the total hours of CPAP use divided by the number of days observed for the patient over the course of a year. | From enrollment until 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Nightly CPAP Use | Mean CPAP use will be the total hours of CPAP use divided by the number of days observed for the patient over the course of the designated time interval. | From enrollment to 30 days, 90 days, and 6 months. |
| Patient and Bed Partner Quality of Sleep |
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Inclusion Criteria - Patient:
Inclusion Criteria - Bed Partner
Exclusion Criteria - Patient:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marquisha Marbury | Contact | 216-778-8484 | mmarbury@metrohealth.org |
| Name | Affiliation | Role |
|---|---|---|
| John Thornton, MD, MPH | MetroHealth System, Ohio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The MetroHealth System | Cleveland | Ohio | 44109 | United States |
Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.
Data will be available from 1 to 4 years after the conclusion of the study.
Those with access to NHLBI BioData Catalyst will have access to study data.
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CPAP telemonitoring and feedback Behavioral couple therapy Couple peer motivators
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| Virtual Disease Support Group Sessions | Behavioral | Patients will attend 3 virtual webinars on prevention and management of diseases affecting the Black community including hypertension, obesity, cardiovascular disease, and cancer led by African American providers. |
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| Couple CPAP Training and Education | Behavioral | Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting. |
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| Couples Virtual OSA Support Group Sessions | Behavioral | Patient and their bed partner will participate in 3 virtual group sessions moderated by an African American patient with longstanding OSA who regularly uses CPAP and their bed partner. |
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| CPAP Tele-monitoring and Feedback | Behavioral | Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use. |
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| Couples' Cognitive Behavioral Therapy | Behavioral | Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners. |
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Epworth Sleepiness Scale |
| From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Patient and Bed Partner Quality of Sleep | PROMIS Sleep Disturbance Index | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Patient and Bed Partner Quality of Sleep | PROMIS Sleep-Related Impairment | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Patient and Bed Partner Quality of Sleep | Functional Outcomes of Sleep short version | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Patient and Bed Partner Quality of Sleep | Actigraphy Data | 6 months |
| Patient and Bed Partner Quality of Life | General quality of life will be assessed using the SF-12 | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Patient and Bed Partner Sleep Apnea Quality of Life | Sleep apnea-related quality of life will be assessed using the Calgary Sleep Apnea Quality of Life Index. | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Sleep Apnea Beliefs | Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale. | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Sleep Apnea Knowledge | Sleep apnea knowledge will be assessed using the Apnea Knowledge Test. | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| Self-efficacy to Use CPAP | Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA). | From enrollment to 30 days, 90 days, 6 months, and 1 year. |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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