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Behavioral Approach for CPAP Adherence in Sleep Apnea
N/A
Recruiting
Led By John D Thornton, MD, MPH
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be at least 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial aims to see if a behavioral approach can help African Americans with sleep apnea better use CPAP machines.
Who is the study for?
This trial is for African American adults over 18 with obstructive sleep apnea who have had the same bed partner for at least six months. Participants must speak English and be able to comply with sleep apnea management, but cannot join if they are terminally ill, have severe sleep apnea, mental incompetence, unstable housing or need advanced breathing support.Check my eligibility
What is being tested?
The study is testing whether a behavioral intervention using telemonitoring, peer support, and CPAP education can help improve adherence to CPAP therapy compared to usual care in African Americans with obstructive sleep apnea.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications, side effects may include discomfort from wearing the CPAP device more frequently or potential privacy concerns related to telemonitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CPAP Adherence
Secondary outcome measures
Patient and Partner Quality of Sleep
Patient and Partner Sleepiness
Sleep Apnea Quality of Life
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Couple InterventionExperimental Treatment4 Interventions
Patients will receive usual care. In addition, they will participate in virtual OSA support groups led by an African American peer-motivator 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.
Telemonitoring. Patients and bed partners will receive text messages encouraging CPAP adherence.
Group II: ControlActive Control1 Intervention
Patients with CPAP technical difficulties will be encouraged to contact the sleep technologist for assistance. Patients will also attend a 90-minute virtual webinar and question-answer session on hypertension management (1 month), cancer screening (3 months), and weight management (6 months) led by African American physicians with expertise in each topic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700
Telemonitoring
2010
N/A
~4980
Find a Location
Who is running the clinical trial?
MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,369 Total Patients Enrolled
2 Trials studying Sleep Apnea
191 Patients Enrolled for Sleep Apnea
John D Thornton, MD, MPHPrincipal InvestigatorMetroHealth System
5 Previous Clinical Trials
5,091 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am not able to make decisions for myself due to mental incapacity.You do not have a stable place to live.You need to use BPAP or VPAP machines for breathing support.You have a very serious illness with no known cure.You stop breathing or have shallow breathing more than 15 times per hour.You do not follow the treatment plan for obstructive sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: Couple Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals of a younger age bracket being included in the research trial?
"To be eligible for this trial, participants must range from 18 to 80 years old. Separately, there are 40 trials specifically targeting those under the age of 18 and 180 geared towards individuals aged 65 or older."
Answered by AI
Which populations are eligible to join this clinical research study?
"This study is recruiting 20 participants who suffer from sleep apnea and are between the ages of 18-80."
Answered by AI
What is the current scope of participants in this medical study?
"Affirmative. Clinicaltrial.gov provides evidence that this medical trial is actively recruiting participants as of July 12th, 2023. Originally posted on February 1st, the study seeks to enrol a total of 20 patients at one centre."
Answered by AI
Are recruitment efforts ongoing for this medical experiment?
"Per the information accessible on clinicaltrials.gov, enrolling patients is still ongoing for this research trial. It was initially announced to the public on February 1st 2023 and edited more recently in July 12th of that same year."
Answered by AI
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