Behavioral Strategies for Sleep Apnea

(BOOST Trial)

Not yet recruiting at 1 trial location

Overseen By Erin E Der-mcleod

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Unstable illness, Dementia, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program can help people with untreated sleep apnea adhere to their therapy more effectively. It tests a decision-making tool that, when combined with a supportive program, might improve sleep quality and increase the use of sleep apnea treatments. Participants will receive either a new, enhanced sleep education program (Behavioral strategy program X plus Y) or a standard one to compare their effectiveness. This trial suits those referred for a sleep test to check for sleep apnea and who have not received treatment in the past year. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep apnea treatment strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on sleep apnea treatment, so it's best to discuss your medications with the study team.

What prior data suggests that these behavioral strategy programs are safe for improving sleep apnea treatment adherence?

Previous studies have closely examined behavioral methods for managing sleep apnea. Research shows these methods are generally safe and well-tolerated. A review of many studies found no major safety concerns with programs designed to help people use their sleep apnea treatments more effectively. These programs often combine education and support to help people adhere to their treatments, improving sleep quality and overall health.

The specific program tested in this trial includes two parts: a strategy program "X" and an additional component "Y." Although detailed safety data for these exact programs is not available, past research suggests that behavioral strategies are safe. These programs usually focus on promoting healthier habits and ensuring regular use of sleep apnea devices, which typically doesn't involve direct medical risks.

In summary, while specific safety data for the new program "X plus Y" is not available, existing evidence suggests that similar behavioral programs are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for sleep apnea involve devices like CPAP machines or oral appliances, which can be cumbersome and uncomfortable for some people. However, researchers are excited about the behavioral strategy program X plus Y because it focuses on enhancing therapy adherence through education and behavior modification. This program is unique because it involves a brief, four-session series with a sleep specialist, emphasizing practical behavioral strategies to boost the effectiveness of existing sleep apnea treatments. Unlike the conventional approach, which primarily targets the physical aspects of sleep apnea, this program aims to empower patients with knowledge and habits that improve their overall treatment experience and outcomes.

What evidence suggests that these behavioral strategy programs could be effective for sleep apnea?

Studies have shown that programs encouraging the use of sleep apnea treatments can help patients use these treatments more regularly, though improvements are often modest. Research indicates that combining behavioral strategies can have a positive impact. For example, one study found that using positive airway pressure (PAP) devices significantly reduced the severity of sleep apnea and daytime sleepiness. Another study showed lasting improvements in sleep patterns and blood oxygen levels in patients who followed structured behavioral programs. In this trial, participants will be assigned to either the behavioral strategy program X or the combined program X plus Y. These findings suggest that the behavioral strategy program X plus Y could improve sleep quality and help patients adhere to their treatments better. ^{1 2 5 6 7}

Who Is on the Research Team?

Constance H Fung, MD MSHS

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with obstructive sleep apnea (OSA). Participants should be willing to use a decision-making tool and engage in a supportive program designed to help them manage their condition.

Inclusion Criteria

I have not been treated for sleep apnea in the past year.

Referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period

Exclusion Criteria

I cannot attend study visits in person or via video.

Unable to read printed material (e.g., magazine) in English language

Unable to write

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a 4 session program to improve adherence to OSA treatment

8 weeks

1 self-directed session, 3 sessions with sleep providers

Follow-up

Participants are monitored for sleep quality and therapy adherence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral strategy program X
• Behavioral strategy program X plus Y

Trial Overview The study is testing two behavioral strategy programs aimed at improving the use of OSA treatments. Program X plus Y includes an additional support element, while Program X is the standard approach.

How Is the Trial Designed?

Group I: Sleep education program X + Y Experimental Treatment 1 Intervention

Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.

Group II: Sleep education program X Active Control 1 Intervention

Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547021/

Effect of sleep apnoea interventions on multiple health outcomes This umbrella review identified CPAP as the most effective intervention for reducing AHI and daytime sleepiness in patients with OSA, while ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025004626

Effect of sleep apnoea interventions on multiple health ... This umbrella review identified CPAP as the most effective intervention for reducing AHI and daytime sleepiness in patients with OSA, while physical activity ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7638

Treatment of Adult Obstructive Sleep Apnea With Positive ... The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...

5. mdpi.com mdpi.com/2077-0383/13/19/5748

Effectiveness of Treating Obstructive Sleep Apnea by ... This real-world, repeated-measure follow-up study found significant and sustained improvements in AHI, minimum O2 saturation, and hypersomnia following sleep ...

6. thorax.bmj.com thorax.bmj.com/content/80/5/300

Six early CPAP-usage behavioural patterns determine ... Results GMM identified six distinct CPAP-usage behaviour patterns over month 1. In four (54% of patients), CPAP-usage increased or decreased, in two (remaining ...

7. link.springer.com link.springer.com/article/10.1007/s40675-016-0051-2

An Update on Behavioural Interventions for Improving ... The psychological model combines coping style, mood, stress and motivation along with health beliefs, attitudes to sleep difficulties, ...