Clinical trial NCT05955287: CPAP Adherence Pilot Study Among African Americans
Official title: A Pilot Study to Determine the Feasibility of a Couples' Oriented Intervention to Promote CPAP Adherence Among African American Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Keywords: obstructive sleep apnea
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the intervention group, patients with OSA and their bed partners will participate in two 1-hour video support groups at 2 weeks and 2 months ran by patients with OSA and their bed partners. Patients with OSA and their bed partners will be contacted in their preferred manner (text messages, email, or phone call) periodically (no more than 4 per week) to determine how well they slept, to encourage them to use their CPAP, or to remind them to contact study staff if they are having difficulty using their CPAP.
Primary purpose: TREATMENT

Brief summary: The goal of the study is to determine the feasibility of a behavioral intervention to improve CPAP adherence among African American patients with obstructive sleep apnea.

Detailed description: The Investigators propose to pilot test a couple-oriented intervention in a randomized controlled trial of 20 African American patients diagnosed with moderate to severe OSA and their partners. Half of the patients will receive optimal usual care currently implemented at MetroHealth, consisting of sleep therapist-initiated standardized education about OSA, sleep hygiene, and CPAP use; personalized mask fittings; and follow-up at 1 week to troubleshoot problems with CPAP utilization. Participants will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of guideline-recommended best practices for improving CPAP adherence consisting of sleep therapist-initiated standardized education for couples about OSA, sleep hygiene, and CPAP use; personalized mask fittings; and follow-up at 1 week to troubleshoot problems with CPAP utilization. Couples will participate in two couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive five 60-minute virtual cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine that will focus on enhancing couples' knowledge of CPAP, patients' self-efficacy to use CPAP, couple's relationship dynamics, and partners' skill and self-efficacy in assisting the patient with CPAP adherence.

Eligibility criteria: Inclusion Criteria:

* Must have same bed partner(s) for at least 6 months.
* Must be at least 18 years of age

Exclusion Criteria:

* Must be Proficient in speaking English
* Non-compliance to management of OSA
* Apnea hypopnea Index ≥ 15 events/hours
* Terminally ill
* Mentally incompetent
* unstable housing
* need for BPAP or VPAP\\PAP).

Primary outcomes:
measure: CPAP Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Apnea Quality of Life
timeFrame: 3 months
measure: Patient and Partner Sleepiness
timeFrame: 3 months
measure: Patient and Partner Quality of Sleep
timeFrame: 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical System
state: Ohio
Study officials:
affiliation: MetroHealth System, Ohio
name: John D Thornton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: