RecruitingNot ApplicableNCT05678088

Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

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

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

45 participants

Start Date

Mar 28, 2023

Study Type

INTERVENTIONAL

Conditions

Obstructive Sleep Apnea

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

Min Age: 18 Years

Inclusion Criteria3

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.

Exclusion Criteria7

Planned airway surgery, use of CPAP, a dental appliance, or other equipment-based treatment modality to manage OSA during the course of the study
Central respiratory events account for ≥50% of the overall apnea-hypopnea index
Reduced cognition (MoCA<18)
Any significant neurological condition that could impact oropharyngeal activity
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
Use of a medical device that would interfere with the use of the home sleep apnea test
Plans to move to another city during the study that would impact compliance.