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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL160836 | U.S. NIH Grant/Contract | View source |
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The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care. | |
| Control group | No Intervention | Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OurSleepKit | Behavioral | OurSleepKit is developed as an app including a patient version and a partner version, to be downloaded on the patient's or partner's mobile devices at home. The goal of OurSleepKit is to coach mutual engagement and model positive partner involvement in CPAP treatment, thus motivating greater CPAP adherence. Using OurSleepKit, both the patient and partner will complete periodic assessments tracking various aspects of their sleep and CPAP use. The assessment data are then processed by OurSleepKit to provide customized and dynamically updated support content consisting of brief story-telling videos featuring real-life couples' experiences emphasizing positive dyadic coping and problem-solving strategies. OurSleepKit delivers timely tailored prompts through push notifications on the users' mobile devices' screens, linked to relevant support content, to facilitate positive conversation in the dyad and offer in-the-moment support for CPAP use. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP adherence | Average hours of nightly CPAP use over the course of the first six months of treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy | Self-Efficacy Measure for Sleep Apnea (SEMSA) is a 26-item validated instrument that contains 3 subscales: risk perception of OSA, outcome expectancies of CPAP, and treatment self-efficacy. Internal consistency was reported as 0.90 for the total scale and 0.85 to 0.89 for the 3 subscales. Reported test-retested reliabilities ranged from 0.68 to 0.77.96 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lichuan Ye, PhD | Contact | 617-373-2582 | l.ye@northeastern.edu | |
| Jack Johnson, BS | Contact | 5082460704 | jac.johnson@northeastern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeastern University | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
The final dataset will be shared per NIH policy after the completion and publication of the main analyses. The final research data will not contain any patient identifiers.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Functional Status | Functional Outcomes of Sleep Questionnaire (FOSQ) is a 30-item disease-specific measure to assess the impact of excessive daytime sleepiness on activities of daily living. It includes five subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcomes. The potential range for each subscale is 1-4, with a total score of 5-20. Higher scores on the FOSQ indicate better daily functioning. The FOSQ has established content validity, test-retest reliability (0.90), internal consistency (0.96), and concurrent validity with standardized generic measures of functional status. | 6 months |
| Health-Related Quality of life | Quality of life will be measured by the 12-item Short Form Health Survey (SF-12). The SF-12 is a validated short form survey with 12 questions selected from the SF-36 Health Survey. The questions are scored to provide evaluations into mental and physical functioning and overall health-related quality of life. | 6 months |
| Dyadic Coping | The Dyadic Coping Inventory (DCI) is a 37-item questionnaire that assesses stress communication and dyadic coping as perceived by each partner about his or her own coping, each partner's perception of the other's coping, and each partner's view of how they cope as a couple on a scale from 1 (very rarely) to 5 (very often). There are four subscales measuring types of dyadic coping: delegated, supportive, stress communication, and negative dyadic coping. | 6 months |
| Daytime Sleepiness | Epworth Sleepiness Scale (ESS) includes items about the likelihood of falling asleep in eight soporific situations. The ESS significantly correlates with the frequency of apneic episodes and is a clinical and research standard in the assessment of daytime sleepiness. It has high test-retest reliability (0.82) and internal consistency (0.88). | 6 months |
| Sleep Quality and Sleep-related Impairment | Patient-Reported Outcomes Information System (PROMISĀ®) assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.The PROMIS Sleep-Related Impairment focuses on self- reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Both tools can readily discriminate patient and control groups, and are sensitive to treatment. | 6 months |
| Partner Involvement in CPAP Treatment | A brief questionnaire with 6 validated items will be used, including three subscales: pressure (asked about using CPAP, tried to persuade you to use CPAP, dropped hints about using CPAP), collaboration (helped solve a problem with CPAP, helped with the CPAP machine), and support (felt supported for using CPAP) on a scale from 1 (not at all) to 5 (extreme). We have used paired versions (one for patient and one for partner) for dyadic evaluation. | 6 months |
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |