Recruiting

OurSleepKit

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT06621511

Conditions

Obstructive Sleep Apnea

CPAP Treatment

Treatment Adherence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OurSleepKit

Study Details

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 ID

NCT06621511

Start date

Dec 3, 2024

Status verified date

Jan, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients should be males or females (ageā‰„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

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention group

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

no intervention: Control group

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

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.

Primary outcome measure

  • CPAP adherence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lichuan Ye, PhD

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

Jack Johnson, BS

5082460704jac.johnson@northeastern.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sanjay Patel, MD

patelsr2@upmc.edu

Principal Investigator:

Sanjay Patel, MD

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-02-03.