OurSleepKit To Support CPAP Adherence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
OurSleepKit
BehavioralOurSleepKit 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 0 interventions
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
CPAP adherence
Average hours of nightly CPAP use over the course of the first six months of treatment
Time frame
6 monthsSecondary outcomes
1
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
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 months4
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.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov