Clinical trial NCT06621511: OurSleepKit to Support CPAP Adherence
Official title: OurSleepKit: a Couple-focused M-Health Intervention to Support Adherence to CPAP Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
CPAP Treatment
Treatment Adherence
Keywords: Obstructive Sleep Apnea
CPAP Treatment
Mobile Health
Treatment Adherence
Dyadic Coping
Couple
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2024-10-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: CPAP adherence
timeFrame: 6 months
Secondary outcomes:
measure: Self-efficacy
timeFrame: 6 months
measure: Functional Status
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Dyadic Coping
timeFrame: 6 months
measure: Daytime Sleepiness
timeFrame: 6 months
measure: Sleep Quality and Sleep-related Impairment
timeFrame: 6 months
measure: Partner Involvement in CPAP Treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: