Breathing and Drinking Exercises for Sleep Apnea

NP
KM
Overseen ByKathleen M. Moran, Ed.D
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Uniformed Services University of the Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different breathing and drinking exercises can help people with obstructive sleep apnea (OSA) improve their sleep. Participants will try either high-resistance or low-resistance exercises to determine which offers better sleep outcomes over three months. The study also examines whether a history of traumatic brain injury (TBI) affects the results. It suits those newly diagnosed with OSA or those who haven't found success with typical treatments and are willing to pause other treatments for three months.

As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires participants to stop their current sleep apnea treatment for 3 months. If you are on other medications, the protocol does not specify whether you need to stop them.

What prior data suggests that these breathing and drinking exercises are safe for people with sleep apnea?

Research shows that myofunctional therapy, which includes exercises for the mouth and throat, can improve sleep in people with obstructive sleep apnea. This therapy can reduce the apnea-hypopnea index (AHI), which measures how often breathing is disrupted during sleep. Studies suggest that AHI can decrease by about 50% in adults and 62% in children.

For more effort-intensive exercises, like breathing and drinking, research indicates that myofunctional therapy may reduce daytime sleepiness and snoring. Conversely, exercises requiring less effort focus on improving muscle tone and have shown similar benefits. Both types of exercises are generally well-tolerated with few reported side effects.

Overall, these treatments appear safe and may enhance sleep without the usual side effects of more invasive treatments.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for sleep apnea because they explore non-invasive, exercise-based approaches to improving airway function. Unlike traditional treatments like CPAP machines or oral appliances, which mechanically assist breathing, these exercises focus on strengthening and toning muscles involved in breathing and swallowing. High-resistance breathing and drinking exercises aim to provide a more natural and potentially more comfortable solution by enhancing the body's own ability to maintain open airways during sleep. By potentially reducing reliance on devices, these methods might also improve patient adherence and long-term outcomes.

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

Research has shown that myofunctional therapy, which includes breathing exercises, can improve sleep in people with obstructive sleep apnea (OSA). One study found that participants experienced fewer breathing interruptions during sleep after three months of therapy. Their apnea-hypopnea index (AHI), a measure of sleep apnea severity, decreased from 22.4 to 13.7. Another study discovered that mouth exercises might reduce snoring and daytime sleepiness, common issues for those with OSA. In this trial, participants will engage in either high-resistance or low-resistance breathing and drinking exercises, both of which could enhance sleep quality in individuals with OSA.12367

Are You a Good Fit for This Trial?

This trial is for individuals with obstructive sleep apnea (OSA), with or without a history of traumatic brain injury (TBI). Participants should be willing to perform daily breathing and drinking exercises. Specific eligibility criteria are not provided, but typically include age range, OSA severity, and absence of conditions that could interfere with the study.

Inclusion Criteria

I have been newly diagnosed with sleep apnea or my first treatment didn't work.
I can follow instructions and do the exercises as required.
I am between 18 and 65 years old.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo HydroBreathe Therapy involving daily exercises with a water bottle and breathing device for 3 months

12 weeks
Bi-weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with optional assessments

3 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • High-Resistance Breathing and Drinking Exercises
  • Low-Resistance Breathing and Drinking Exercises

Trial Overview

The study compares two types of behavioral interventions over three months: one involving low-resistance and the other high-resistance breathing and drinking exercises. It aims to see which improves sleep quality more in people with OSA, including those who have had a TBI.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Myofunctional TherapyExperimental Treatment1 Intervention
Group II: Relaxation TherapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials
130
Recruited
91,100+

Citations

Low-Tech Treatments for Obstructive Sleep Apnea

The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and ...

Obstructive sleep apnea: focus on myofunctional therapy

The results obtained in an RCT showed that, after three months of therapy, patients with moderate OSA had a significant reduction of AHI (22.4±4.8 vs 13.7±8.5) ...

Orofacial Myofunctional Therapy for Patients with ...

Continuous positive airway pressure (CPAP) therapy is considered the gold standard and effectively reduces apneic events and health risks [3], ...

The role of oral myofunctional therapy in managing ...

Results: There was significant decrease of apnea hypopnea index (AHI), arousal index after myofunctional therapy as compared to before myofunctional therapy (p ...

Myofunctional therapy (oropharyngeal exercises) for ...

Compared to waiting list, myofunctional therapy may reduce daytime sleepiness, may result in little to no difference in sleep quality and may reduce AHI.

Myofunctional Therapy to Treat Obstructive Sleep Apnea

Current literature demonstrates that myofunctional therapy decreases apnea-hypopnea index by approximately 50% in adults and 62% in children.

Myofunctional training with negative airway pressure for ...

8 Both as a stand-alone therapy and in conjunction with PAP, OMT has been shown to reduce the apnea hypopnea index (AHI), reduce snoring, and ...