Swallowing Exercises for Obstructive Sleep Apnea

(SLP-PAP Trial)

Overseen By Denise Dewald, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Denise Dewald

Must not be taking: Stimulants, Opioids

Disqualifiers: Swallowing disorders, Neuromuscular disorders, Complex sleep apnea, Unstable illness, others

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

Compensation: Varies

Number of Visits: 3

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study has two parts: an observational part and an interventional part. The goal of the observational part of the study is to look for variations in swallowing in adults with obstructive sleep apnea (OSA) and in adults who don't snore. The main questions it aims to answer are: * Are there differences in swallowing between people with OSA and people who don't snore? * Are there differences in swallowing between people with OSA who do well with continuous positive airway pressure (CPAP) therapy and those who struggle with CPAP? This may help us better understand what causes OSA, which may help us develop alternate ways to treat or even prevent OSA. It may also help us improve care for people with OSA who struggle with CPAP. Participants will be aged 40-60 years, except women up to the age of 70 will be included in the healthy control (non-snorer) group. Participants will: * Undergo a type of x-ray study called a modified barium swallow study (MBS) * Come to MetroHealth Medical Center for a measurement visit to: * assess the strength of their tongue, lips, and cheeks * assess the strength of their breathing muscles * assess for restrictions in tongue mobility (tongue ties) * observe their resting breathing * take photos of their mouth and posture * take videos of them drinking and eating * Complete some questionnaires * For successful CPAP users: we will download data from the chip in their CPAP device * Do a home sleep test (except for successful CPAP users who have had a recent in-lab sleep test) The goal of the interventional part of the study is to test swallowing exercises in people ages 40-60 years with OSA who struggle with CPAP. The main question it aims to answer is: • Can swallowing exercises help people who struggle with CPAP sleep better with CPAP? Participants will: * Try to use CPAP for 2 weeks with individualized support * Do all the investigations listed in the observational part of the study * Do one or two courses of swallowing exercises, each of which would last 7 weeks. Participants will be asked to do daily exercises; exercises will take 20-30 minutes to perform. * Try to use CPAP for 2 weeks after the course of exercises * Repeat the investigations listed in the observational part of the study to see if changes occurred with the swallowing exercise intervention.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, certain conditions and medication use are part of the exclusion criteria, so it's best to discuss your specific situation with the trial coordinators.

What data supports the effectiveness of the treatment Myofunctional Exercises, SLP Swallowing Exercises for Obstructive Sleep Apnea?

Research shows that myofunctional therapy, which includes exercises for the mouth and throat, can help improve obstructive sleep apnea by strengthening muscles and reducing airway collapse during sleep. ^{1 2 3 4 5}

Is myofunctional therapy safe for humans?

The available evidence suggests that myofunctional therapy, which includes swallowing exercises, is a safe treatment for improving sleep-disordered breathing conditions like obstructive sleep apnea. ^{1 2 3 5 6}

How do swallowing exercises differ from other treatments for obstructive sleep apnea?

Swallowing exercises, also known as myofunctional therapy, are unique because they focus on strengthening the muscles of the mouth and throat to prevent airway collapse during sleep. Unlike other treatments like CPAP machines or surgery, these exercises are non-invasive, cost-effective, and aim to provide long-lasting improvements by enhancing muscle tone. ^{1 2 5 6 7}

Research Team

Denise Dewald, MD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for adults aged 40-60 with obstructive sleep apnea (OSA) who find it hard to use CPAP, and healthy adults without snoring issues. Participants should have a BMI between 18.5 and 35, not miss more than four natural teeth due to decay or accident, and have used CPAP successfully for over a year with no sleep complaints.

Inclusion Criteria

I do not snore.

My teeth align naturally well without braces, including my wisdom teeth.

I do not have any sleep-related complaints.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Observational

Participants undergo a modified barium swallow study (MBS) and a measurement visit to assess swallowing differences between groups.

2-4 weeks

2 visits (in-person)

Interventional

Participants with CPAP intolerance perform swallowing exercises for 7 weeks, followed by a 2-week CPAP trial.

9 weeks

Weekly follow-up visits (virtual or in-person)

Follow-up

Participants are monitored for changes in CPAP tolerance and swallowing function post-intervention.

3-7 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Long-term assessment of CPAP use and effectiveness of swallowing exercises.

3-15 months

Phone follow-up and CPAP compliance downloads

Treatment Details

Interventions

• Myofunctional Exercises
• SLP Swallowing Exercises

Trial Overview The study observes swallowing differences in OSA patients versus non-snorers and tests if myofunctional or SLP swallowing exercises can help OSA patients better tolerate CPAP therapy. It includes x-rays, muscle strength assessments, questionnaires, home sleep tests, and exercise courses lasting seven weeks each.

Participant Groups

Group I: CPAP intolerant - SLP exercises only Experimental Treatment 1 Intervention

CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and a measurement visit. During the measurement visit their oral and respiratory strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out questionnaires. Participants with abnormalities on their MBS will get a 7-week course of standard swallowing exercises, with weekly in-person visits with a speech pathologist. They will be expected to do daily exercises (which will take 20-30 minutes). They will then try to use CPAP for two weeks to see if they are able to use CPAP better. If they do well with CPAP or are still struggling with CPAP but do not want to continue onto the myofunctional therapy arm, they will do an MBS, home sleep test, questionnaires, and the measurement visit again.

Group II: CPAP intolerant - SLP and OMT Experimental Treatment 2 Interventions

CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and also a measurement visit. During the measurement visit their oral and respiratory strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out questionnaires. Participants with abnormalities on their MBS will get standard swallowing exercises based on the abnormalities. They will then try using CPAP for two weeks. If they do not improve their CPAP tolerance with standard swallowing exercises, they will do a course of myofunctional therapy exercises. Both courses will be 7 weeks long, with daily exercises to do at home lasting 20-30 min. They will then repeat the home sleep test, MBS, questionnaires, and measurement visit, and will try using CPAP for two weeks to see if they can use CPAP better.

Group III: CPAP intolerant - OMT exercises only Experimental Treatment 1 Intervention

CPAP intolerant participants will try to use CPAP for two weeks with individualized coaching. If they still have problems with CPAP, they will do a modified barium study (MBS), a baseline home sleep test, and also a measurement visit. During the measurement visit their oral and respiratory strength, tongue mobility, nasal airflow, eating and drinking, dental and facial form, and posture will be assessed. They will also fill out some questionnaires. CPAP intolerant participants without abnormalities on their MBS will get oral myofunctional therapy (OMT) exercises. The course of exercises will take 7 weeks to complete, with weekly video follow up visits. The exercises will take 20-30 minutes to do over the course of the day. After completing the 7-week course, participants will repeat the home sleep test, modified barium study, questionnaires, and measurement visit, and will once more try using CPAP for two weeks to see if they are able to use CPAP better.

Group IV: Healthy airways group Active Control 1 Intervention

Participants will get a home sleep test to verify that sleep disordered breathing is not present. They will do a modified barium study (MBS) and a measurement visit to assess oral and respiratory muscle strength, nasal airflow, tongue mobility, eating and drinking, dental and facial form, and posture. They will also fill out some questionnaires.

Group V: Successful CPAP user Active Control 1 Intervention

Participants who do well will CPAP will do a modified barium study (MBS) and a measurement visit to assess oral and respiratory muscle strength, tongue mobility, nasal airflow, eating and drinking, dental and facial form, and posture. They will also fill out some questionnaires. Participants will also provide their CPAP data on an SD card. Participants will also do a home sleep test if there is no recent sleep study available.

Who Is Running the Clinical Trial?

Denise Dewald

Lead Sponsor

Trials

1

Recruited

50+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Findings from Research

Myofunctional therapy (MT) significantly reduces the apnea-hypopnea index (AHI) in patients with obstructive sleep apnea (OSA), showing a large effect size with scores decreasing from an average of 28.0 to 18.6 events per hour based on a meta-analysis of 15 studies involving 237 patients.

MT also improves lowest oxygen saturation (LSAT) levels and reduces daytime sleepiness, as indicated by a decrease in the Epworth Sleepiness Scale (ESS) scores, demonstrating its efficacy as a treatment for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofunctional therapy for OSA: a meta-analysis. Meghpara, S., Chohan, M., Bandyopadhyay, A., et al.[2022]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Myofunctional therapy for OSA: a meta-analysis. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. Canada pubmed.ncbi.nlm.nih.gov

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

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

Myofunctional therapy improves adherence to continuous positive airway pressure treatment. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Myofunctional Therapy in Treating Sleep-Disordered Breathing: A State-of-the-Art Review. [2021]

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

Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

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