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Behavioral Education for Sleep Apnea
N/A
Recruiting
Led By Cathy A Alessi, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of moderate to severe obstructive sleep apnea (apnea hypopnea index [AHI] > or = 15)
Previously prescribed positive airway pressure (PAP) therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test the effects of an education program specifically designed for middle-aged and older Veterans who have stopped using their PAP device, or are not using it regularly, in order to improve sleep, function and quality of life.
Who is the study for?
This trial is for middle-aged and older Veterans with moderate to severe sleep apnea who have stopped or are irregular in using their PAP therapy. They must not have used PAP in the last 30 days but were previously prescribed it. Those with severe mental health issues, unstable medical conditions, or significant cognitive impairment cannot participate.Check my eligibility
What is being tested?
The study tests two educational programs aimed at encouraging regular use of PAP devices among Veterans with sleep apnea. Participants will work with a 'sleep coach' over five sessions and receive follow-up calls for six months to see if this improves adherence.See study design
What are the potential side effects?
Since the interventions are educational, there are no direct medical side effects from drugs or procedures. However, participants may experience stress or discomfort discussing their health habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with severe sleep apnea (AHI >= 15).
Select...
I have been prescribed a PAP machine before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PAP adherence
Secondary outcome measures
Daytime sleepiness
Sleep quality
Sleep-related function
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Education Intervention IExperimental Treatment1 Intervention
Manual-based education program provided in individual sessions
Group II: Behavioral Education Intervention IIActive Control1 Intervention
Manual-based education program provided in individual sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Education Intervention I
2018
N/A
~220
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,227 Total Patients Enrolled
8 Trials studying Sleep Apnea
1,003 Patients Enrolled for Sleep Apnea
Cathy A Alessi, MD MPHPrincipal InvestigatorVA Greater Los Angeles Healthcare System, Sepulveda, CA
Cathy A Alessi, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, Sepulveda, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with severe sleep apnea (AHI >= 15).You have major problems with thinking and remembering.You haven't been using your PAP machine regularly in the past month.I have been prescribed a PAP machine before.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Education Intervention I
- Group 2: Behavioral Education Intervention II
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 there any open slots left for participation in this research endeavor?
"Affirmative, the online clinicaltrials.gov registry indicates that this medical study is presently recruiting participants. It was put up on October 10th 2022 and its most recent revision occurred on January 2nd 2022. 225 patients are needed to be sourced from a single location."
Answered by AI
What is the current cap on enrollees for this research trial?
"Affirmative, the information hosted on clinicaltrials.gov verifies that this medical research is still searching for patients. It was initially posted on 10th January 2022 and edited lastly at 1st February of the same year. A total amount of 225 participants are needed from a singular site to complete this trial."
Answered by AI
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