Behavioral Education for Sleep Apnea

Overseen By Cathy A Alessi, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe psychopathology, Unstable illness, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

234 Participants Needed

Trial Summary

What is the purpose of this trial?

Sleep apnea is a common problem in middle-aged and older Veterans that is associated with poor nighttime sleep, more daytime sleepiness, poor functioning and worse quality of life. The recommended therapy for most patients with sleep apnea is positive airway pressure (PAP) therapy; however, over time many patients prescribed PAP therapy no longer use it regularly. This study 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. Eligible Veterans who are enrolled into the study will receive a baseline assessment that includes questionnaires about sleep, health, and quality of life. After completing the baseline assessment, participants will be randomly assigned to one of two education groups. Both groups will meet individually with a "sleep coach" for 5 session over 8 weeks, then they will be contacted monthly by telephone for up to 6 months. Participants will complete follow-up assessments immediately after the fifth education session and again at 6-months and 12-months. If successful, this approach has the potential to improve sleep, function and quality of life in middle-aged and older Veterans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education for sleep apnea rather than medication changes.

What data supports the effectiveness of the treatment Behavioral Education Intervention I, Behavioral Education Intervention II for sleep apnea?

Research shows that educational and motivational interventions can improve adherence to treatments like CPAP for sleep apnea. Programs that include motivational strategies and problem-based learning have been effective in helping patients stick to their treatment plans. ^{1 2 3 4 5}

Is Behavioral Education for Sleep Apnea safe for humans?

The research articles provided do not contain specific safety data for Behavioral Education for Sleep Apnea or its related interventions. ^{1 2 6 7 8}

How does the Behavioral Education Intervention for sleep apnea differ from other treatments?

The Behavioral Education Intervention for sleep apnea is unique because it focuses on educating and motivating patients to improve adherence to treatments like CPAP (continuous positive airway pressure) by using motivational interviewing and feedback, rather than relying solely on mechanical or pharmaceutical solutions. ^{1 2 4 7 9}

Research Team

Cathy A Alessi, MD MPH

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with severe sleep apnea (AHI >= 15).

You haven't been using your PAP machine regularly in the past month.

I have been prescribed a PAP machine before.

Exclusion Criteria

Severe psychopathology (e.g., active psychosis) that precludes participation in the study

Severe unstable medical illness that precludes participation in the study

You have major problems with thinking and remembering.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete questionnaires about sleep, health, and quality of life

1 week

1 visit (in-person)

Treatment

Participants receive a manual-based education program with a sleep coach over 5 sessions

8 weeks

5 visits (in-person)

Monthly Follow-up

Participants are contacted monthly by telephone for up to 6 months

6 months

6 visits (virtual)

Follow-up

Participants complete follow-up assessments at 6-months and 12-months

12 months

2 visits (in-person)

Treatment Details

Interventions

• Behavioral Education Intervention I
• Behavioral Education Intervention II

Trial Overview 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.

Participant Groups

Group I: Behavioral Education Intervention I Experimental Treatment 1 Intervention

Manual-based education program provided in individual sessions

Group II: Behavioral Education Intervention II Active Control 1 Intervention

Manual-based education program provided in individual sessions

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The Kansas Infant Death and SIDS (KIDS) Network Safe Sleep Instructor training significantly improved the knowledge of safe sleep recommendations among Child Protective Services (CPS) staff, who initially had lower baseline knowledge compared to other participants.

CPS staff, after receiving the training, went on to provide more safe sleep education to professionals than their counterparts, demonstrating the program's effectiveness in enhancing community training efforts to prevent sleep-related infant deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Promotion: Increasing Capacity of Child Protective Services Employees. Ahlers-Schmidt, CR., Schunn, C., Hervey, AM., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of augmented continuous positive airway pressure education and support on compliance and outcome in a Chinese population. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Adherence to APAP in obstructive sleep apnea syndrome: effectiveness of a motivational intervention. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A mixed method evaluation of a group-based educational programme for CPAP use in patients with obstructive sleep apnea. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Controlled Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Tailored Approach to Sleep Health Education (TASHE): a randomized controlled trial of a web-based application. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Promotion: Increasing Capacity of Child Protective Services Employees. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of Infant Behavioral Sleep Intervention in a Diverse Sample of Mothers. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on the efficacy of audio-visual health educational materials on CPAP adherence: the AHEAD trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Behavioral control of abnormal breathing in sleep. [2019]