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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for obstructive sleep apnea (OSA) using oropharyngeal exercises. These exercises target muscles in the mouth and throat and may serve as an alternative to traditional CPAP machines, which some find difficult to use. The trial will assess whether these exercises alleviate sleep apnea symptoms such as daytime sleepiness and mood disturbances. Individuals with OSA who cannot or choose not to use CPAP might be suitable for this study. Participants will use an app for exercises and will be placed in different study groups to determine the most effective approach. As an unphased trial, this study provides a unique opportunity for participants to explore innovative treatments that could enhance their quality of life.

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 prior data suggests that oropharyngeal exercises are safe for treating sleep apnea?

Research shows that exercises to strengthen the mouth and throat muscles, known as oropharyngeal exercises, are generally easy for people to perform. Studies have found that these exercises can help reduce symptoms of obstructive sleep apnea (OSA), such as daytime sleepiness. Reports of serious side effects are rare, suggesting these exercises are safe for most individuals.

Although these exercises might not reduce sleep apnea severity as effectively as CPAP (a machine that keeps the airway open during sleep), they appear harmless. They could be a suitable option for those who struggle with CPAP use. Evidence so far suggests these exercises are a safe alternative for managing sleep apnea symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these oropharyngeal exercises for obstructive sleep apnea because they offer a non-invasive alternative that could strengthen tongue and throat muscles, potentially reducing sleep apnea symptoms. Unlike standard treatments like CPAP machines that require wearing a mask during sleep, these exercises are done through an app, making them more accessible and user-friendly. Additionally, the option of supervised or unsupervised exercises provides flexibility, potentially increasing adherence and effectiveness. By exploring muscle training as a treatment, this approach could lead to lasting improvements without the need for devices or surgery.

What evidence suggests that oropharyngeal exercises could be an effective treatment for sleep apnea?

Research has shown that mouth and throat exercises, known as myofunctional therapy, can help reduce symptoms of obstructive sleep apnea (OSA). In this trial, participants will join different arms to evaluate the effectiveness of these exercises. Compared to sham exercises, which some participants will perform, these oropharyngeal exercises likely reduce daytime sleepiness and may improve sleep quality. Some studies indicate that while these exercises cannot fully replace CPAP (continuous positive airway pressure), they improve scores on the Epworth Sleepiness Scale (ESS), which measures daytime sleepiness. Another study found that these exercises led to a significant decrease in the apnea-hypopnea index (AHI), which measures how often breathing stops and starts during sleep. Overall, these exercises show promise as a potential alternative for those who cannot use CPAP effectively. ^{1 2 4 6 7}

Who Is on the Research Team?

Mark I Boulos, MD, MSc

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33141943/

Myofunctional therapy (oropharyngeal exercises) for ... Compared to sham therapy, myofunctional therapy probably reduces daytime sleepiness and may increase sleep quality in the short term.

2. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013449.pub2/full

Myofunctional therapy (oropharyngeal exercises) for ... Compared to sham therapy, myofunctional therapy probably reduces daytime sleepiness and may increase sleep quality in the short term in patients ...

3. nature.com nature.com/articles/s41598-024-79884-0

Effect of 10-minute oropharyngeal exercise on the apnoea ... Studies have shown that oropharyngeal exercises improve the AHI. However, it is difficult to continue oral exercises for 30 min a day for 3 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8094400/

Myofunctional therapy (oropharyngeal exercises) for ... Compared to standard medical treatment, myofunctional therapy may reduce daytime sleepiness (MD ‐6.40 points, 95% CI ‐9.82 to ‐2.98; one study, 26 participants; ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1532338225000521

Efficacy of myofunctional therapy for obstructive sleep apnea Limited evidence of direct and indirect comparisons showed that while MT cannot replace CPAP in reducing AHI, both MTSP and MT alone significantly improve ESS.

6. database.inahta.org database.inahta.org/article/33317

[Myofunctional therapy (oropha - International HTA Database Compared to CPAP, myofunctional therapy was not superior in any evaluated outcomes. CPAP was significantly more effective in reducing AHI. However, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6792506/

Myofunctional therapy (oropharyngeal exercises) for ... To evaluate the benefits and harms of myofunctional therapy (oropharyngeal exercises) for the treatment of obstructive sleep apnoea.