Oropharyngeal Exercises for Obstructive Sleep Apnea

Overseen By Sarah Berger, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Hypnotics, Opiates

Disqualifiers: Planned airway surgery, Neurological conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 10 weeks

45 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 7}

Research Team

Mark I Boulos, MD, MSc

Principal Investigator

Sunnybrook Health Sciences Centre

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.

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

Treatment Details

Interventions

• Oropharyngeal Exercises
• Sham Exercises

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Findings from Research

Oropharyngeal exercises, a non-invasive treatment for mild to moderate obstructive sleep apnea, significantly improved symptoms such as daytime sleepiness and snoring intensity in a study of 20 patients over 3 months.

The therapy also led to better sleep quality, as indicated by improvements in sleep indices like oxygen saturation and total sleep time, while neck circumference decreased, suggesting enhanced pharyngeal muscle tone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal exercises in the treatment of obstructive sleep apnoea: our experience. Verma, RK., Johnson J, JR., Goyal, M., et al.[2022]

A 6-week tongue elevation training program for patients with moderate obstructive sleep apnea (OSA) did not significantly reduce the severity of OSA as measured by the apnea-hypopnea index (AHI).

However, the training did lead to significant improvements in daytime sleepiness and tongue endurance, with 75% of participants experiencing a clinically meaningful reduction in daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of tongue elevation muscle training in patients with obstructive sleep apnea: A randomised controlled trial. Poncin, W., Correvon, N., Tam, J., et al.[2023]

Orofacial myofunctional therapy (OMT) significantly improves key measures of obstructive sleep apnea (OSA) in adults, including a reduction in the apnea-hypopnea index (AHI) and subjective sleepiness, based on a systematic review of 7 randomized control trials involving 310 patients.

In contrast, OMT showed limited effectiveness in children with OSA due to poor compliance, highlighting the need for further research on adherence and long-term outcomes of OMT in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. Saba, ES., Kim, H., Huynh, P., et al.[2023]

Myofunctional therapy, which includes oropharyngeal and tongue exercises, significantly reduced snoring intensity by 51% in adults, as measured by visual analog scale scores, indicating its efficacy as a treatment for snoring.

The therapy also led to a 31% reduction in the percentage of total sleep time spent snoring, demonstrating its potential to improve sleep quality for individuals suffering from snoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. Camacho, M., Guilleminault, C., Wei, JM., et al.[2022]

In a pilot study involving 40 patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS), the use of a mobile health app for oropharyngeal exercises led to a significant 53.4% reduction in apnea-hypoxia index (AHI), indicating improved severity of the condition.

The intervention group also showed notable improvements in tongue and lip strength, as measured by the Iowa Oral Performance Instrument (IOPI), and a significant decrease in daytime sleepiness, as reflected by the Epworth Sleepiness Scale, suggesting that the app-based therapy is an effective and promising treatment for OSAHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. O'Connor-Reina, C., Ignacio Garcia, JM., Rodriguez Ruiz, E., et al.[2021]

Oro-facial myofunctional therapy (OMT) significantly reduces the apnea-hypopnea index (AHI) and improves lowest oxygen saturation levels in patients with mild and moderate obstructive sleep apnea (OSA), based on a systematic review of 13 studies.

OMT is a non-invasive treatment option that also decreases daytime sleepiness (measured by the Epworth Sleepiness Scale) and reduces snoring intensity, making it a beneficial therapy for managing OSA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of oro-facial myofunctional therapy in treating obstructive sleep apnoea: A meta-analysis of observational studies. Zhang, F., Tian, Z., Shu, Y., et al.[2022]

Orofacial myofunctional therapy (OMT) has been shown to effectively reduce the severity of obstructive sleep apnea (OSA) in both adults and children, leading to improvements in apnea-hypopnea index (AHI), oxygen saturation, and overall quality of life.

Despite the positive outcomes observed, the review highlights a lack of high-quality randomized studies and emphasizes the need for long-term evaluations to better understand the effects of OMT on upper airway musculature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea: focus on myofunctional therapy. de Felício, CM., da Silva Dias, FV., Trawitzki, LVV.[2023]

References

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

Oropharyngeal exercises in the treatment of obstructive sleep apnoea: our experience. [2022]

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]

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

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. [2023]

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

Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. [2022]

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

Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. [2021]

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]

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

Obstructive sleep apnea: focus on myofunctional therapy. [2023]