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Behavioral Education for Sleep Apnea

N/A
Waitlist Available
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
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with severe sleep apnea (AHI >= 15).
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I have been prescribed a PAP machine before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PAP adherence
Secondary study objectives
Daytime sleepiness
Sleep quality
Sleep-related function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,574 Total Patients Enrolled
7 Trials studying Sleep Apnea
631 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

Behavioral Education Intervention I Clinical Trial Eligibility Overview. Trial Name: NCT04868682 — N/A
Sleep Apnea Research Study Groups: Behavioral Education Intervention I, Behavioral Education Intervention II
Sleep Apnea Clinical Trial 2023: Behavioral Education Intervention I Highlights & Side Effects. Trial Name: NCT04868682 — N/A
Behavioral Education Intervention I 2023 Treatment Timeline for Medical Study. Trial Name: NCT04868682 — N/A
~49 spots leftby Aug 2025
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