OurSleepKit To Support CPAP Adherence

National Institutes of Health (NIH)

Status

Enrolling

Conditions

CPAP Treatment

Treatment Adherence

Obstructive Sleep Apnea

Treatments

Behavioral: OurSleepKit

Study type

Interventional

Funder types

NIH

Identifiers

NCT06621511

IRB #: 24-04-26

R01HL160836 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.