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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 who are also not using an equipment-based treatment modality (e.g. PAP therapy, a dental appliance, or hypoglossal nerve stimulation) or surgery to manage their OSA.
Must not have
Use of medications that may impact tone of the upper airway (e.g. hypnotics, opiates) ≥3 nights per week during the 4 weeks prior to randomization
Any significant neurological condition that could impact oropharyngeal activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.
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.
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.
Select...
I am not using devices or surgery to treat my sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've been using medications like sleeping pills or painkillers more than 3 nights a week for the last month.
Select...
I have a neurological condition affecting my throat or swallowing.
Select...
I plan to use a device like CPAP or dental appliance for my sleep apnea during the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability to ascertain Obstructive Sleep Apnea (OSA) severity
Patient adherence with the study exercises
Rate of recruitment
Secondary study objectives
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
671 Previous Clinical Trials
1,564,590 Total Patients Enrolled
Mark Boulos, MD, MScPrincipal InvestigatorSunnybrook Health Sciences Centre
1 Previous Clinical Trials
21 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, Unsupervised Oropharyngeal Exercises, Supervised Sham 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
~6 spots leftby Jan 2025
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