Strengthening Oropharyngeal Muscles as a Novel Approach to Treat Obstructive Sleep Apnea: A Randomized Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to determine whether a randomized controlled trial using oropharyngeal exercises to treat sleep apnea is feasible. Continuous positive airway pressure (CPAP) is the standard therapy for Obstructive sleep apnea (OSA), but it is poorly tolerated by many patients. Oropharyngeal exercises (OPEs) which are commonly used by speech-language pathologists to improve oro-motor strength, may serve as a promising alternative approach. The main questions this study aims to answer are: * Is it feasible to use an oropharyngeal exercise protocol in patients with sleep apnea? * Will oropharyngeal exercises improve sleep apnea severity, daytime sleepiness, sleep quality, mood, workplace performance, and quality of life Participants will be randomized into a supervised OPE intervention arm vs. unsupervised OPE intervention arm vs. sham treatment for a 10-week/5-day per week/two 20-minute session exercise protocol. The exercises will be administered via an app and the investigators will assess feasibility, as well as several sleep-related and oro-motor physiological outcomes before treatment, immediately post-treatment, and 4 weeks post-treatment. The investigators will use the results of this feasibility trial to inform the sample size needed for a larger clinical trial that will determine the efficacy of using oropharyngeal exercises to treat OSA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 unwilling to use CPAP or have been unable to tolerate CPAP after at least a 2-week trial

• 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.

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Mark Boulos, MD, MSc
mark.boulos@sunnybrook.ca
416-480-4473
Backup
Sarah Berger, MSc
sarah.berger@sri.utoronto.ca
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2026-03
Participants
Target number of participants: 45
Treatments
Experimental: Supervised Oropharyngeal Exercises
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.
Active_comparator: Unsupervised Oropharyngeal Exercises
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.
Sham_comparator: Supervised Sham Exercises
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.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov