Airway Exercises for Obstructive Sleep Apnea

(OSA Trial)

Overseen By Brittney Sullivan, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Benzodiazepines, Narcotics

Disqualifiers: Age, BMI, Alcoholism, A-fib, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effectiveness of mouth exercises using a smartphone app versus paper instructions for individuals with obstructive sleep apnea (OSA), a condition that causes snoring and interrupted breathing during sleep. Participants will either use an app or follow paper guides to perform the exercises. It suits individuals with mild to severe OSA who have not found success with CPAP (a common sleep apnea treatment) or other treatments. As an unphased trial, this study provides a unique opportunity to explore new methods for managing OSA symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use benzodiazepine hypnotics (a type of medication that can affect muscle tone).

What prior data suggests that these airway exercises are safe for improving sleep apnea?

Past research has shown that airway exercises are safe and well-tolerated by people with sleep apnea. Participants noticed improvements in their symptoms. One study found that these exercises reduced breathing pauses during sleep by nearly 10 times per hour. Another study suggested that these exercises improved the overall severity of sleep apnea.

Reports of unwanted side effects are rare. However, some people may find it challenging to maintain the exercise routine, especially if it requires significant daily time. Overall, the exercises are considered safe and could be a helpful addition to managing sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage obstructive sleep apnea (OSA) through airway exercises. Unlike traditional treatments like CPAP machines or oral appliances, which can be cumbersome and uncomfortable, this trial tests two unique methods: a mobile app and paper forms guiding mouth exercises. The app provides a tech-friendly, convenient way to perform and track exercises, appealing to those who prefer digital solutions. Meanwhile, the paper-based method offers a low-tech alternative that can be easily integrated into daily routines. Both approaches aim to empower patients to manage their condition with simple exercises, potentially offering a more comfortable and accessible alternative to current options.

What evidence suggests that these airway exercises might be effective for sleep apnea?

Research shows that airway exercises can greatly help people with obstructive sleep apnea (OSA). Studies have found that these exercises can reduce the severity of sleep apnea, measured by the apnea-hypopnea index (AHI), by about half in adults. One study reported a 39% reduction in AHI with similar exercises. In this trial, participants will be divided into two groups: the App Group, where a phone application guides and tracks mouth exercises, and the Analog Group, where exercise and tracking are done using paper forms. These exercises strengthen the muscles around the throat and mouth, helping to keep airways open during sleep. Overall, evidence suggests that these exercises can effectively reduce sleep apnea symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Juan M Palomo, DDS, MSD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for individuals who snore or have obstructive sleep apnea. Participants should be willing to use a mobile app or a hardcopy guide to perform airway exercises designed to improve their condition.

Inclusion Criteria

I have sleep apnea and cannot use CPAP or other treatments.

Exclusion Criteria

BMI > 40

Alcoholism or drug abuse

Restricted tongue movement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform airway exercises using either a mobile phone app or a hardcopy guide

12 weeks

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study is testing the effectiveness of using a mobile phone app versus a hardcopy guide for performing airway exercises in people with snoring and obstructive sleep apnea issues.

How Is the Trial Designed?

Group I: App Group Active Control 1 Intervention

The mouth exercises are guided and tracked by a phone application.

Group II: Analog Group Active Control 1 Intervention

The exercise and tracking is done using paper forms.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

American Association of Orthodontists Foundation

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

Patients with obstructive sleep apnea (OSA) have low levels of physical activity, averaging only 5,388 steps per day, which is significantly below the recommended 10,000 steps.

Exercise training in OSA patients leads to a meaningful reduction in apnea-hypopnea events (average decrease of 8.9 events/hour) and improves cardiorespiratory fitness (VO2peak), while also reducing feelings of sleepiness, indicating that exercise can be an effective intervention for managing OSA severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive Sleep Apnea Syndrome, Objectively Measured Physical Activity and Exercise Training Interventions: A Systematic Review and Meta-Analysis. Mendelson, M., Bailly, S., Marillier, M., et al.[2020]

Inspiratory muscle training (IMT) over 12 weeks significantly improved sleep quality in patients with obstructive sleep apnea (OSA), as measured by the Pittsburgh Sleep Quality Index, compared to a placebo group.

However, IMT did not lead to significant improvements in lung function, respiratory muscle strength, or exercise capacity, indicating that while it may enhance sleep quality, it does not affect overall physical performance in OSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of inspiratory muscle training on sleep and functional capacity to exercise in obstructive sleep apnea: a randomized controlled trial. Souza, AKF., Dornelas de Andrade, A., de Medeiros, AIC., et al.[2019]

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]

In a study of 62 patients with obstructive sleep apnea (OSA), treatment with continuous positive airway pressure (CPAP) significantly improved both sleep quality and physical activity levels over 3 to 7 months, with participants averaging an increase of 1431 steps per day by the end of the study.

The results showed that poor sleep quality was linked to lower physical activity at baseline, highlighting the importance of effective OSA treatment in enhancing both sleep and activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in Physical Activity in Persons With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure. Jean, RE., Duttuluri, M., Gibson, CD., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4402674/

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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0422763816301583

Upper airway muscle exercises outcome in patients with ... This results was in accordance with the study of Guimaraes, who concluded that use of group oropharyngeal exercises for OSA reduced AHI by 39% and significantly ...

3. atsjournals.org atsjournals.org/doi/10.1164/rccm.200806-981OC

Effects of Oropharyngeal Exercises on Patients with ... This randomized controlled trial showed that oropharyngeal exercises developed for the treatment of OSAS significantly reduced OSAS severity and symptoms.

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8318

Effects of respiratory muscle therapy on obstructive sleep apnea Our meta-analyses showed that the patients receiving upper airway muscle therapy had the largest improvement in AHI, with an average of −9.6 events/h ...

5. 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 ...

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

Myofunctional therapy (oropharyngeal exercises) for ... Compared to CPAP plus myofunctional therapy, myofunctional therapy alone may result in little to no difference in daytime sleepiness and may increase AHI.

7. mdpi.com mdpi.com/2411-5142/10/3/253

Exploring Exercise Interventions for Obstructive Sleep Apnea Conclusions: Overall, the findings suggest that exercise, regardless of its regime, benefits individuals with OSA. Keywords: obstructive sleep apnea; OSA; ...