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Oropharyngeal Exercises for Obstructive Sleep Apnea

N/A
Recruiting
Led By Mark Boulos, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with OSA (defined as an apnea-hypopnea index ≥10/hr) in whom >50% of the respiratory events are obstructive in nature
Patients with OSA (defined as an apnea-hypopnea index ≥10/hr) in whom >50% of the respiratory events are obstructive in nature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test the feasibility of oropharyngeal exercises as an alternative treatment for sleep apnea, with a focus on patient outcomes, feasibility, and sample size.

Who is the study for?
This trial is for people with moderate to severe obstructive sleep apnea who don't want or can't tolerate CPAP therapy. They shouldn't be using other equipment-based treatments, have plans to move during the study, take certain medications affecting airway tone often, or have conditions that could interfere with exercises.Check my eligibility
What is being tested?
The study tests if doing special throat exercises can help treat sleep apnea. Participants will do these exercises through an app either under supervision or on their own, or get a sham treatment for comparison. The goal is to see if this method is practical and improves various health aspects related to sleep apnea.See study design
What are the potential side effects?
Since the intervention involves non-invasive exercises, significant side effects are not expected. However, participants may experience fatigue of the oro-motor muscles due to the exercise regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have OSA with mostly obstructive events.
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I have OSA with mostly obstructive events.
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I am not using devices or surgery to treat my sleep apnea.
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I cannot or will not use CPAP for my sleep issues.
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I am not using devices or surgery to treat my sleep apnea.
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I cannot or will not use CPAP for my sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to ascertain Obstructive Sleep Apnea (OSA) severity
Patient adherence with the study exercises
Rate of recruitment
Secondary outcome measures
Acceptability, Appropriateness, and Feasibility of Intervention Measure
Change in Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Change in Lowest Oxygen Desaturation
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Supervised Oropharyngeal ExercisesExperimental Treatment1 Intervention
The participant will perform the oropharyngeal exercises that strengthen the tongue and pharyngeal muscles. The protocol will be delivered via a tablet-based app. The speech language pathologist will call or conduct videoconference visits with participants 1, 3, 5, 7 and 9 weeks after the baseline assessment to provide re-training (if needed) and to troubleshoot technical issues related to the use of the app.
Group II: Unsupervised Oropharyngeal ExercisesActive Control1 Intervention
The participant will perform the oropharyngeal exercises that strengthen the tongue and pharyngeal muscles. The protocol will be delivered via a tablet-based app. After the initial training there will be no further scheduled interactions with the study staff except during the follow-up telephone calls and study visits.
Group III: Supervised Sham ExercisesPlacebo Group1 Intervention
The participant will perform sham control exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength. The speech language pathologist will call or conduct videoconference visits with participants 1, 3, 5, 7 and 9 weeks after the baseline assessment to provide re-training (if needed) and to troubleshoot technical issues related to the use of the app.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,252 Total Patients Enrolled
Mark Boulos, MD, MScPrincipal InvestigatorSunnybrook Health Sciences Centre
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Oropharyngeal Exercises Clinical Trial Eligibility Overview. Trial Name: NCT05678088 — N/A
Obstructive Sleep Apnea Research Study Groups: Supervised Oropharyngeal Exercises, Supervised Sham Exercises, Unsupervised Oropharyngeal Exercises
Obstructive Sleep Apnea Clinical Trial 2023: Oropharyngeal Exercises Highlights & Side Effects. Trial Name: NCT05678088 — N/A
Oropharyngeal Exercises 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678088 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05678088 — N/A

Frequently Asked Questions

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

Are there any enrolment opportunities available at this time for those interested in participating?

"According to clinicaltrials.gov, this therapeutic trial is not currently recruiting any more individuals into the study. This investigation was first reported on January 1st 2023 and last updated three days later; however, there are numerous other trials that are actively looking for participants right now - a total of 270 at present."

Answered by AI

What is the overarching objective of this scientific inquiry?

"The primary evaluation of this trial, conducted over the course of two years, will be to assess participant compliance with study-mandated protocols. Secondary assessments include changes in lowest oxygen desaturation (which can be measured using a home sleep monitor), alterations in objective sleep quality (assessed through wrist actigraphy provided by a home sleep apnea test) and variations in objective sleep quantity (also determined via wrist actigraphy)."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How much would I have to travel?
PatientReceived no prior treatments

Why did patients apply to this trial?

I was just diagnosed with severe sleep apnea. I think the physical therapy is a great idea!! I have not recieved my CPAP yet.
PatientReceived 2+ prior treatments
~19 spots leftby Jan 2025