CPAP Adherence Pilot Study Among African Americans

Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955287
• Other study ID #: STUDY00000055
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2023
• Source: MetroHealth Medical Center
• Contact: John D Thornton, MD,MPH
• Phone: 216-778-3732
• Email: dthornton[@]metrohealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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.
• 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.
• 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
• Usual Care
Participants will receive OSA education and CPAP training from providers trained in OSA management.

Locations

Country	Name	City	State
United States	MetroHealth Medical System	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP Adherence	Mean hours per night of CPAP use	3 months
Secondary	Sleep Apnea Quality of Life	Calgary Sleep Apnea Quality of Life Index. 84 items with higher scores suggesting higher quality of life	3 months
Secondary	Patient and Partner Sleepiness	Epworth Sleepiness Scale (ESS) - 8 items, with scoring range 0 - 24. Higher scores are associated with increased sleepiness.	3 months
Secondary	Patient and Partner Quality of Sleep	Functional Outcomes of Sleep Questionnaire (FOSQ-10) Patient and Partner Functional Status assessed in 10 questions with lower scores suggesting worse outcomes	3 months