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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if swallowing exercises (myofunctional exercises and SLP swallowing exercises) can help individuals with obstructive sleep apnea (OSA) improve their ability to sleep better with CPAP, a common sleep apnea treatment. It will also explore differences in swallowing between individuals with OSA and those who don't snore, as well as between OSA patients who use CPAP successfully and those who do not. The trial seeks participants aged 40-60 with OSA who struggle with CPAP, and those without sleep complaints or snoring issues. Individuals with OSA who find CPAP uncomfortable or difficult to use, or those who don’t snore and have naturally aligned teeth, may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding alternative treatments for sleep apnea.

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 prior data suggests that these swallowing exercises are safe for people with obstructive sleep apnea?

Research has shown that myofunctional therapy, involving exercises for the mouth and throat, has been studied for its effects on obstructive sleep apnea (OSA). A review of studies found this therapy generally safe, though it might not significantly improve certain measures of OSA severity, such as the apnea-hypopnea index (AHI), which counts how often breathing stops during sleep. However, it strengthens muscles, potentially aiding in managing OSA symptoms.

Another study examined swallowing exercises led by speech-language pathologists (SLP) and found improvement in swallowing for people with high blood pressure and OSA. This suggests the therapy is safe and could benefit those with swallowing issues related to OSA. Overall, both myofunctional and SLP swallowing exercises appear well-tolerated, with no major safety concerns reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obstructive sleep apnea (OSA) because they offer a non-invasive and potentially more accessible alternative to the standard continuous positive airway pressure (CPAP) therapy, which many patients find intolerable. Myofunctional and swallowing exercises aim to strengthen the muscles involved in breathing and swallowing, potentially improving airway function and reducing sleep apnea symptoms without the need for a machine. These exercises can be done at home, making them a convenient option for patients. By focusing on improving muscle function, these treatments could help improve CPAP tolerance or even reduce the need for CPAP altogether, offering new hope for those struggling with traditional therapies.

What evidence suggests that these swallowing exercises might be an effective treatment for obstructive sleep apnea?

Research has shown that myofunctional therapy, one of the treatments studied in this trial, can significantly aid people with obstructive sleep apnea (OSA). Studies have found that this therapy can reduce sleep disruptions by about 50% in adults, offering a potential alternative for those who struggle with CPAP machines. Myofunctional exercises strengthen the muscles around the mouth and throat, which can enhance breathing during sleep.

Similarly, swallowing exercises led by speech-language pathologists, another treatment option in this trial, have shown positive results. People with OSA have reported better swallowing and improved sleep after these exercises. This therapy targets the muscles used for swallowing and can also enhance breathing during sleep. Both therapies are being evaluated in this trial for their potential benefits in managing OSA, particularly for those who find CPAP challenging to use. ^{2 6 7 8 9}

Who Is on the Research Team?

Denise Dewald, MD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

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.

I do not have any sleep-related complaints.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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/S1532338225000521

Efficacy of myofunctional therapy for obstructive sleep apnea This systematic review and network meta-analysis of randomized controlled trials (RCTs) aims to evaluate the efficacy of MT in treating adult and pediatric OSA.

3. pajr.researchcommons.org pajr.researchcommons.org/cgi/viewcontent.cgi?article=1190&context=journal

The role of oral myofunctional therapy in managing ... Results: There was significant decrease of apnea hypopnea index (AHI), arousal index after myofunctional therapy as compared to before myofunctional therapy (p ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41045206/

An Overview and Re-Analysis of Systematic Reviews This overview with re-analysis of systematic reviews (SRs) aims to assess the effectiveness of orofacial myofunctional therapy (MT) for ...

5. resmedjournal.com resmedjournal.com/article/S0954-6111(25)00523-2/fulltext

Telemedicine-supported structured Orofacial Myofunctional ... The dataset contains 126 rows and 39 columns, with diverse information on patient demographics, treatment types, body mass index, daytime ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37606313/

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea The objective of this systematic review and meta-analysis is to determine the efficacy of OMT in OSA patients. Data sources: PubMed/Medline, EMBASE, Cochrane, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04608552

NCT04608552 | Effect of Myofunctional Therapy on OSA The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.

8. 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, ...

9. 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.