OurSleepKit To Support CPAP Adherence

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT06621511
Status
Recruiting
Apply to this trial

Conditions

  • CPAP Treatment
  • Obstructive Sleep Apnea
  • Treatment Adherence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 3, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

CPAP adherence [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northeastern UniversityBostonMassachusetts02115
Lichuan Ye, PhD
[email protected]
617-373-2582
Jack johnson, BS
[email protected]
5082460704
Lichuan Ye, PhD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Sanjay Patel, MD
[email protected]
Sanjay Patel, MD (PRINCIPAL_INVESTIGATOR)

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