OurSleepKit to Support CPAP Adherence

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea; CPAP Treatment; Treatment Adherence
• Interventions: Behavioral: OurSleepKit

• Registration Number: NCT06621511
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-12-03
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2028-01-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year
• The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
• both partners should have their own mobile devices with access to the internet

Exclusion Criteria

• have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder)
• have planned bariatric surgery (as they typically quit CPAP after surgery)
• have a partner using CPAP
• are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
• couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	OurSleepKit	Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care.

Primary Outcome Measures

Name	Time	Method
CPAP adherence	6 months	Average hours of nightly CPAP use over the course of the first six months of treatment

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	6 months	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
Functional Status	6 months	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.
Quality of life	6 months	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.
Dyadic Coping	6 months	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.
Daytime Sleepiness	6 months	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).
Sleep Quality and Sleep-related Impairment	6 months	Patient-Reported Outcomes Information System (PROMIS®) 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.
Partner Involvement in CPAP Treatment	6 months	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.

Trial Locations

Locations (4)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Northeastern University; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States