← Back to Search

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

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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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.

0 / 5Eligibility criteria met