Mindfulness Program for Sleep Apnea

Overseen By Jun Au

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Developmental delay, Neuromuscular disorders, Central sleep apnea, Severe psychiatric illnesses, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mindfulness program can improve the use of CPAP machines for sleep apnea. Researchers aim to determine if practicing mindfulness is more effective than receiving online peer support. Participants will either join a mindfulness program, such as Mindfulness-Based Stress Reduction or Mindfulness-Based Cognitive Therapy, or participate in an online group to share experiences and advice. Teens aged 13-18 with moderate or severe sleep apnea who can consent for themselves are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing sleep apnea.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this mindfulness program is safe for improving CPAP use?

Research has shown that mindfulness programs are generally safe and easy to use. In one study, mindfulness meditation helped individuals with long-term sleep problems sleep better, without any serious side effects. Another study found that mindfulness breathing exercises reduced stress and improved mental flexibility, with no major issues reported.

Mindfulness-based stress reduction (MBSR) has also improved sleep quality in various groups, such as individuals with spinal cord injuries. These studies suggest that mindfulness can be a safe alternative to medication for sleep problems.

Overall, the evidence supports the safety of mindfulness programs, making them a promising option for improving sleep and reducing stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Program for sleep apnea because it approaches treatment from a psychological angle, focusing on mindfulness and stress reduction rather than the physical interventions like CPAP machines or oral appliances. Unlike typical treatments that aim to keep airways open, this program teaches adolescents skills to enhance awareness and resilience, potentially improving sleep quality through mental and emotional well-being. This innovative approach may offer a complementary or alternative solution for those who struggle with standard sleep apnea treatments.

What evidence suggests that this mindfulness program is effective for sleep apnea?

Research has shown that mindfulness programs can help improve sleep problems. In this trial, participants in one arm will attend the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program, which studies have found can reduce sleep issues, particularly for those with anxiety or depression. Mindfulness-based stress reduction can also decrease symptoms of obstructive sleep apnea (OSA), such as excessive daytime sleepiness. Additionally, mindfulness therapy can significantly lower insomnia and nighttime worry. These findings suggest that a mindfulness program might be a helpful treatment for improving sleep in people with sleep apnea. ^{2 6 7 8 9}

Who Is on the Research Team?

Indra Narang, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for teens aged 13-18 with a confirmed diagnosis of moderate or severe Obstructive Sleep Apnea (OSA) who can consent to participate. It's not suitable for those with neuromuscular disorders, limited English proficiency, developmental delays that prevent participation, central sleep apnea, or severe psychiatric conditions.

Inclusion Criteria

I am a teenager and can make my own medical decisions.

I have been diagnosed with moderate or severe sleep apnea.

Exclusion Criteria

I have a developmental delay that prevents me from participating in studies.

I have a neuromuscular disorder.

Limited knowledge and proficiency in English to complete the study as judged by the clinical team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend either an online mindfulness program or an online peer support program

8 weeks

Online sessions

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Program

Trial Overview The study aims to see if practicing mindfulness can help improve the use of CPAP machines in treating OSA compared to getting support from online peers. Participants will be assigned to either learn mindfulness techniques or join an online peer support group.

How Is the Trial Designed?

Group I: Mindfulness Program Active Control 1 Intervention

Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program.

Group II: Online Peer Support Program Active Control 1 Intervention

Participants will attend an online peer support program where they will engage with each other by sharing experiences while providing advice and emotional support.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9048455/

Effects of mindfulness-based intervention programs on ... All MBI programs (MBTT, MBCT, IMMI and MBSR), except MM, are effective options to improve sleep problems among people with depression or anxiety disorder.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S138994572300117X

Effects of mindfulness meditation and Acceptance ... Assessing the effects of Mindfulness-Based Stress Reduction (MBSR) on symptoms of OSA, especially on the primary outcome, excessive daytime sleepiness (EDS) ...

3. nature.com nature.com/articles/s41598-025-23727-z

Effects of mindfulness breathing meditation on stress and ... The results showed significant improvement in cognitive flexibility and reduction in perceived stress levels after the intervention in the ...

4. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1072752/full

Mindfulness-based therapy for insomnia alleviates ... In a single-arm trial of MBTI, patients reported large reductions in nocturnal cognitive arousal (Cohen's d = 0.95) and insomnia (Cohen's d = ...

5. academic.oup.com academic.oup.com/sleep/article/37/9/1553/2416992

Randomized Controlled Trial of Mindfulness Meditation for ... Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4153063/

A Randomized Controlled Trial of Mindfulness Meditation ... To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Three-arm, single-site, randomized controlled trial.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550830724001447

Effects of mindfulness-based stress reduction therapy for ... To explore the effect of the mindfulness-based stress reduction (MBSR) practice on sleep quality and perceived stress in patients with spinal cord injury (SCI).

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.928940/pdf

Effect of short-term mindfulness-based stress reduction on ... Conclusion: These results suggest that short-term MBSR could improve sleep quality and may serve as an alternative treatment to hypnotics for ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00515177

Mindfulness Versus Pharmacotherapy for Chronic ... Mindfulness meditation training has been found to improve sleep outcomes in patients with chronic illnesses. ... A Mindfulness-Based Stress Reduction (MBSR) ...