Oropharyngeal Exercises for Obstructive Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen by Mark I Boulos, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Hypnotics, Opiates

Disqualifiers: Planned airway surgery, Neurological conditions, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine whether a randomized controlled trial using oropharyngeal exercises to treat sleep apnea is feasible. Continuous positive airway pressure (CPAP) is the standard therapy for Obstructive sleep apnea (OSA), but it is poorly tolerated by many patients. Oropharyngeal exercises (OPEs) which are commonly used by speech-language pathologists to improve oro-motor strength, may serve as a promising alternative approach. The main questions this study aims to answer are: * Is it feasible to use an oropharyngeal exercise protocol in patients with sleep apnea? * Will oropharyngeal exercises improve sleep apnea severity, daytime sleepiness, sleep quality, mood, workplace performance, and quality of life Participants will be randomized into a supervised OPE intervention arm vs. unsupervised OPE intervention arm vs. sham treatment for a 10-week/5-day per week/two 20-minute session exercise protocol. The exercises will be administered via an app and the investigators will assess feasibility, as well as several sleep-related and oro-motor physiological outcomes before treatment, immediately post-treatment, and 4 weeks post-treatment. The investigators will use the results of this feasibility trial to inform the sample size needed for a larger clinical trial that will determine the efficacy of using oropharyngeal exercises to treat OSA.

Will I have to stop taking my current medications?

The trial requires that participants do not use medications that may affect the tone of the upper airway, like hypnotics or opiates, for more than 3 nights a week during the 4 weeks before starting the study.

What data supports the effectiveness of oropharyngeal exercises for obstructive sleep apnea?

Research shows that oropharyngeal exercises, which help strengthen the muscles in the throat, are a new and cost-effective way to treat mild to moderate obstructive sleep apnea. These exercises can reduce the severity of the condition and have long-lasting effects.

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Is oropharyngeal exercise therapy safe for humans?

The research does not specifically mention any safety concerns related to oropharyngeal exercises, suggesting they are generally considered safe for humans.

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How is the treatment of oropharyngeal exercises for obstructive sleep apnea different from other treatments?

Oropharyngeal exercises are a unique, non-invasive treatment for obstructive sleep apnea that work by strengthening the muscles in the throat, which helps keep the airway open during sleep. Unlike other treatments, such as CPAP machines or surgery, these exercises are cost-effective and aim to provide long-lasting results by naturally improving muscle tone.

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Eligibility Criteria

This trial is for people with moderate to severe obstructive sleep apnea who don't want or can't tolerate CPAP therapy. They shouldn't be using other equipment-based treatments, have plans to move during the study, take certain medications affecting airway tone often, or have conditions that could interfere with exercises.

Inclusion Criteria

I have OSA with mostly obstructive events.

I cannot or will not use CPAP for my sleep issues.

I am not using devices or surgery to treat my sleep apnea.

Exclusion Criteria

I've been using medications like sleeping pills or painkillers more than 3 nights a week for the last month.

Use of a medical device that would interfere with the use of the home sleep apnea test

You have significant problems with memory and thinking.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into supervised or unsupervised oropharyngeal exercise arms or a sham treatment arm for a 10-week exercise protocol

10 weeks

5 visits (virtual) for supervised arms

Follow-up

Participants are monitored for changes in OSA severity, sleep quality, and other outcomes post-treatment

4 weeks

Follow-up assessments at 14 weeks

Participant Groups

The study tests if doing special throat exercises can help treat sleep apnea. Participants will do these exercises through an app either under supervision or on their own, or get a sham treatment for comparison. The goal is to see if this method is practical and improves various health aspects related to sleep apnea.

Group I: Supervised Oropharyngeal Exercises Experimental Treatment 1 Intervention

The participant will perform the oropharyngeal exercises that strengthen the tongue and pharyngeal muscles. The protocol will be delivered via a tablet-based app. The speech language pathologist will call or conduct videoconference visits with participants 1, 3, 5, 7 and 9 weeks after the baseline assessment to provide re-training (if needed) and to troubleshoot technical issues related to the use of the app.

Group II: Unsupervised Oropharyngeal Exercises Active Control 1 Intervention

The participant will perform the oropharyngeal exercises that strengthen the tongue and pharyngeal muscles. The protocol will be delivered via a tablet-based app. After the initial training there will be no further scheduled interactions with the study staff except during the follow-up telephone calls and study visits.

Group III: Supervised Sham Exercises Placebo Group 1 Intervention

The participant will perform sham control exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength. The speech language pathologist will call or conduct videoconference visits with participants 1, 3, 5, 7 and 9 weeks after the baseline assessment to provide re-training (if needed) and to troubleshoot technical issues related to the use of the app.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sunnybrook Health Sciences Centre Toronto, Canada

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Oropharyngeal exercises in the treatment of obstructive sleep apnoea: our experience. [2022] Oropharyngeal exercises are new, non-invasive, cost effective treatment modality for the treatment of mild to moderate obstructive sleep apnoea. It acts by increasing the tone of pharyngeal muscles, is more physiological, and effects are long lasting.

2. England pubmed.ncbi.nlm.nih.gov

The effect of tongue elevation muscle training in patients with obstructive sleep apnea: A randomised controlled trial. [2023] Oropharyngeal myofunctional therapy is a multi-component therapy effective to reduce the severity of obstructive sleep apnoea (OSA). However, existing protocols are difficult to replicate in the clinical setting. There is a need to isolate the specific effectiveness of each component of the therapy.

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

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. [2023] Orofacial myofunctional therapy (OMT) is an alternative form of treatment of obstructive sleep apnea (OSA), that incorporates various exercises to optimize tongue placement and increase oropharyngeal tone. The objective of this systematic review and meta-analysis is to determine the efficacy of OMT in OSA patients.

4. Germany pubmed.ncbi.nlm.nih.gov

Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. [2022] Oropharyngeal and tongue exercises (myofunctional therapy) have been shown to improve obstructive sleep apnea. However, to our knowledge, a systematic review has not been performed for snoring. The study objective is to perform a systematic review, with a meta-analysis, dedicated to snoring outcomes after myofunctional therapy.

5. Canada pubmed.ncbi.nlm.nih.gov

Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. [2021] Myofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) to perform oropharyngeal exercises.

6. England pubmed.ncbi.nlm.nih.gov

Efficiency of oro-facial myofunctional therapy in treating obstructive sleep apnoea: A meta-analysis of observational studies. [2022] The literature on oro-facial myofunctional therapy (OMT) in children and adults with obstructive sleep apnoea (OSA) was systematically reviewed to investigate the effects of OMT on patients with OSA by age and disease severity to verify the effect of OMT on OSA.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea: focus on myofunctional therapy. [2023] Orofacial myofunctional therapy (OMT) is a modality of treatment for children and adults with obstructive sleep apnea (OSA) to promote changes in the musculature of the upper airways. This review summarizes and discusses the effects of OMT on OSA, the therapeutic programs employed, and their possible mechanisms of action.