OurSleepKit To Support CPAP Adherence

NCT ID: NCT06621511

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2028-07-31

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.

Conditions

Obstructive Sleep Apnea; CPAP Treatment; Treatment Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

No interventions assigned to this group

Control group

Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OurSleepKit

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northeastern University

Boston, Massachusetts, United States

Site Status: NOT_YET_RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lichuan Ye, PhD

Role: CONTACT

l.ye@northeastern.edu

617-373-2582

Jack Johnson, BS

Role: CONTACT

jac.johnson@northeastern.edu

5082460704

Facility Contacts

Lichuan Ye, PhD

Role: primary

l.ye@northeastern.edu

617-373-2582

Jack johnson, BS

Role: backup

jac.johnson@northeastern.edu

5082460704

Sanjay Patel, MD

Role: primary

patelsr2@upmc.edu

Other Identifiers

R01HL160836

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB #: 24-04-26

Identifier Type: -

Identifier Source: org_study_id