Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05955287
Study type Interventional
Source MetroHealth Medical Center
Contact John D Thornton, MD,MPH
Phone 216-778-3732
Email dthornton@metrohealth.org
Status Recruiting
Phase N/A
Start date February 1, 2023
Completion date May 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT03919955 - A Novel Pharmacological Therapy for Obstructive Sleep Apnea Phase 2
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00747890 - Surgical Treatment of Mild Obstructive Sleep Apnea N/A
Active, not recruiting NCT00738179 - Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease Phase 3
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Completed NCT00202501 - Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome N/A
Completed NCT00047463 - Effects of Treating Obstructive Sleep Apnea in Epilepsy Phase 2
Not yet recruiting NCT06029881 - Portable System for Non-intrusive Monitoring of Sleep
Recruiting NCT06093347 - Central Apnoea Monitor Study
Terminated NCT05445869 - Severe OSA Study (SOS) N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT04575740 - Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea N/A
Completed NCT04676191 - Validation of a Contactless Vital Signs Measurement Sensor N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT06051097 - Metabolic Syndrome and Obstructive Sleep Apnea
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury