NCT05955287

CPAP Adherence Pilot Study Among African Americans

A Pilot Study to Determine the Feasibility of a Couples' Oriented Intervention to Promote CPAP Adherence Among African American Patients With Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
BEHAVIORAL	Telemonitoring	Text messages of encouragement will be sent to patients and partners. No more than 2 messages will be sent per week to prevent respondent fatigue.
BEHAVIORAL	Peer Based	Patients and partners will attend OSA virtual support groups led by an African American patient with long-standing OSA and their bed partner. Peer-motivator couples will be trained and certified as competent prior to interacting with study participants. They will share their experiences with managing OSA including coping strategies to maximize CPAP adherence.
BEHAVIORAL	CPAP Education	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
BEHAVIORAL	Usual Care	Participants will receive OSA education and CPAP training from providers trained in OSA management.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-07-21
• Last updated: 2023-07-21

Locations

1 site across 1 country: United States