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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist middle-aged and older Veterans with sleep apnea who have stopped or aren't regularly using their prescribed PAP (positive airway pressure) devices. It will test two different education programs, Behavioral Education Intervention I and Behavioral Education Intervention II. Each program involves sessions with a "sleep coach" to encourage better use of these devices. The goal is to improve sleep, daytime alertness, and quality of life. Veterans with moderate to severe sleep apnea who haven't used their PAP device in the past 30 days are well-suited for this trial. As an unphased trial, this study offers Veterans an opportunity to explore new ways to enhance their sleep and overall well-being.

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 prior data suggests that this education program is safe for Veterans with sleep apnea?

Research has shown that educational and behavioral programs for sleep apnea are generally safe. These programs encourage more frequent use of sleep machines. Studies have found that they can increase machine usage by over an hour each night. Major safety concerns are absent, as these programs primarily involve teaching and support. However, some studies note the need for more information on long-term safety and adherence to treatment. Overall, these programs are well-received and aim to help patients improve their sleep habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral education interventions for sleep apnea because they offer a non-invasive approach to managing the condition. Unlike standard treatments like CPAP machines or oral appliances, these interventions focus on educating individuals through manual-based programs delivered in individual sessions. This method empowers patients to better understand and manage their sleep apnea, potentially improving adherence and outcomes without the need for equipment or devices. By enhancing patient education, these interventions aim to address the root behaviors contributing to sleep apnea, offering a unique alternative to traditional mechanical treatments.

What evidence suggests that this trial's education programs could be effective for sleep apnea?

Research has shown that educational and behavioral programs can help people with sleep apnea use their CPAP (continuous positive airway pressure) machines more effectively. One study found that these programs increased CPAP use by about 1.31 hours per night compared to regular care. Another study demonstrated a short-term increase in nightly CPAP use by an average of 1.49 hours. In this trial, participants will receive either Behavioral Education Intervention I or Behavioral Education Intervention II, both designed to improve CPAP use. Consistent CPAP use through these programs may enhance sleep quality and overall well-being for people with sleep apnea. ^{4 5 6 7 8}

Who Is on the Research Team?

Cathy A. Alessi, MD

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PAP Adherence Program Experimental Treatment 1 Intervention

Manual-based behavioral treatment to improve PAP adherence and sleep.

Group II: Active Control Active Control 1 Intervention

Manual-based general sleep education program.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32255210/

Educational, supportive and behavioural interventions to ... Educational, supportive and behavioural interventions may help people with OSA initiate and maintain regular and continued use of CPAP.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36635010/

Effectiveness of behavioral and psychosocial interventions ... Behavioral/supportive interventions improved mean nightly CPAP use in both the short term (WMD = 1.49, 95 % CI = 0.16-2.81, p = 0.029, I2 = 30 %, very low ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0897189722000969

Effectiveness of behavioral and psychosocial interventions ... Several interventions have been implemented to improve CPAP adherence since 2013; these are now in need of review in order to determine their effectiveness.

4. aafp.org aafp.org/pubs/afp/issues/2021/1000/p356.html

Interventions to Improve Use of CPAP Machines in Adults ... Behavioral interventions increase CPAP use (mean difference [MD] = 1.31 hours per night; 95% CI, 0.95 to 1.66) compared with usual care.

5. jmir.org jmir.org/2020/2/e16972/

Effectiveness of eHealth Interventions in Improving ... Behavioral interventions were found to have the largest effects on CPAP adherence, followed by supportive interventions and educational ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7137251/

Educational, supportive and behavioural interventions to ... Educational, supportive and behavioural interventions may help people with OSA initiate and maintain regular and continued use of CPAP.

7. cochrane.org cochrane.org/evidence/CD007736_do-supportive-educational-and-behavioural-interventions-improve-usage-continuous-positive-airway

Do supportive, educational and behavioural interventions ... Behavioural therapy increases machine usage by 79 minutes per night, and ongoing supportive interventions probably increase machine use by about ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07207473

Behavioral Optimization to Overcome Obstructive Sleep ... Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests ...