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

Trial Summary

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 data supports the effectiveness of the treatment Exercise for Obstructive Sleep Apnea?

Research shows that exercise can reduce the severity of obstructive sleep apnea (OSA) by decreasing the number of breathing interruptions during sleep. It also improves sleep quality and reduces daytime sleepiness, even though it doesn't change body weight. ^{1 2 3 4 5}

Is airway exercise safe for humans?

Exercise programs, including those with airway exercises, have been studied in people with obstructive sleep apnea and are generally considered safe. They can improve sleep quality and overall health without significant safety concerns. ^{1 6 7 8 9}

How does the treatment of airway exercises for obstructive sleep apnea differ from other treatments?

Airway exercises for obstructive sleep apnea are unique because they are non-invasive and focus on strengthening the muscles in the throat to improve breathing during sleep. Unlike other treatments like CPAP machines or surgery, these exercises are more natural and can have long-lasting effects without the need for medical devices or procedures. ^{1 7 10 11 12}

What is the purpose of this trial?

This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.

Research Team

Juan M Palomo, DDS, MSD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Patients with Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Obstructive Sleep Apnea Syndrome, Objectively Measured Physical Activity and Exercise Training Interventions: A Systematic Review and Meta-Analysis. [2020]

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

Exercise training improves selected aspects of daytime functioning in adults with obstructive sleep apnea. [2021]

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

Effects of exercise training associated with continuous positive airway pressure treatment in patients with obstructive sleep apnea syndrome. [2022]

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

Improvement in Physical Activity in Persons With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure. [2018]

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

A diet and exercise program to improve clinical outcomes in patients with obstructive sleep apnea--a feasibility study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Combined Community Exercise Program in Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Obstructive Sleep Apnea Syndrome: The Effect of Acute and Chronic Responses of Exercise. [2022]

9. Germany 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. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

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

11. Germany pubmed.ncbi.nlm.nih.gov

The effect of oropharyngeal exercise in patients with moderate and severe obstructive sleep apnea using CPAP: a randomized controlled study. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Clinical analysis of pharyngeal musculature and genioglossus exercising to treat obstructive sleep apnea and hypopnea syndrome. [2018]