OurSleepKit To Support CPAP Adherence

NCT06621511 | Recruiting DMC

• 2 other identifiers: IRB #: 24-04-26R01HL160836
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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; Treatment Adherence; CPAP Treatment

Keywords

Obstructive Sleep Apnea; CPAP Treatment; Mobile Health; Treatment Adherence; Dyadic Coping; Couple

Outcome Measures

Primary Outcomes (1)

• CPAP adherence

  Average hours of nightly CPAP use over the course of the first six months of treatment

  6 months

Secondary Outcomes (7)

• Self-efficacy

  6 months

• Functional Status

  6 months

• Health-Related Quality of life

  6 months

• Dyadic Coping

  6 months

• Daytime Sleepiness

  6 months

Study Arms (2)

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.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

Northeastern University

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Health Behavior; Behavior

Central Study Contacts

Lichuan Ye, PhD

CONTACT

617-373-2582; l.ye@northeastern.edu

Jack Johnson, BS

CONTACT

5082460704; jac.johnson@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (2)