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Myofunctional Therapy for Obstructive Sleep Apnea

N/A
Recruiting
Led By Carl J Stepnowsky, Jr., PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old
Confirmed diagnosis of OSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights

Study Summary

This trial is testing whether or not a therapy that consists of exercises to improve breathing can help people with mild to moderate sleep apnea without the use of a medical device.

Who is the study for?
This trial is for adults over 18 with mild-to-moderate Obstructive Sleep Apnea (OSA), fluent in English, receiving care at VA San Diego Healthcare System. It's not for those living outside San Diego County, with a life expectancy under 6 months, cognitive impairments that prevent following the protocol, substance abuse issues or low health literacy.Check my eligibility
What is being tested?
The study tests Orofacial Myofunctional Therapy (OMT) as an alternative to nightly medical devices for OSA. OMT includes exercises targeting mouth and throat muscles to improve breathing during sleep without using cumbersome equipment.See study design
What are the potential side effects?
While specific side effects are not detailed here, OMT generally involves physical exercises which may cause discomfort or fatigue in facial muscles. As it's non-invasive, risks are likely lower than other medical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with obstructive sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)
Secondary outcome measures
Change in Epworth Sleepiness Score (ESS; measure of sleepiness)
Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)
Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Myofunctional TherapyActive Control1 Intervention
Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.
Group II: Inactive Myofunctional TherapyPlacebo Group2 Interventions
Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,044 Total Patients Enrolled
Carl J Stepnowsky, Jr., PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
270 Total Patients Enrolled

Media Library

OMT Exercises Clinical Trial Eligibility Overview. Trial Name: NCT04608552 — N/A
Obstructive Sleep Apnea Research Study Groups: Active Myofunctional Therapy, Inactive Myofunctional Therapy
Obstructive Sleep Apnea Clinical Trial 2023: OMT Exercises Highlights & Side Effects. Trial Name: NCT04608552 — N/A
OMT Exercises 2023 Treatment Timeline for Medical Study. Trial Name: NCT04608552 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively participating in this experiment?

"Indeed, clinicaltrials.gov confirms that this health-related experiment is currently seeking participants. Starting from August 2nd 2021 and updated as recently as February 2nd 2022, 240 people are required to be recruited across one location."

Answered by AI

What populations are eligible to partake in the experiment?

"Eligibility requirements for this medical trial dictate that applicants must be between 18-70 years old and suffer from obstructive sleep apnea. Approximately 240 patients will eventually join the study."

Answered by AI

Does this research require potential participants to be younger than 30 years old?

"This clinical trial is only accepting individuals between the years of 18 and 70. There are 48 trials for minors, while those older than 65 can choose from 235 other studies."

Answered by AI

Is the process of enrollment for this research trial still open?

"Indeed, the data hosted on clinicaltrials.gov confirms that this medical trial is actively searching for volunteers. The initial post was made on August 2nd 2021 and the last update occurred on February 2nd 2022. This experiment seeks 240 participants from 1 location."

Answered by AI

Who else is applying?

What site did they apply to?
VA San Diego Healthcare System, San Diego, CA
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Myofunctional Therapy on OSA
2021. "Effect of Myofunctional Therapy on OSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04608552.
~21 spots leftby Jul 2024
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