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Not Yet Recruiting NCT05678088

Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

Conditions: Obstructive Sleep Apnea

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 45
Sponsor: Sunnybrook Health Sciences Centre

Location: Canada

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 lifeParticipants 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 Criteria

Inclusion Criteria:Patients with OSA (defined as an apnea-hypopnea index ≥10/hr) in whom >50% of the respiratory events are obstructive in naturePatients who are unwilling to use CPAP or have been unable to tolerate CPAP after at least a 2-week trialPatients 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 Criteria:Planned airway surgery, use of CPAP, a dental appliance, or other equipment-based treatment modality to manage OSA during the course of the studyCentral respiratory events account for ≥50% of the overall apnea-hypopnea indexReduced cognition (MoCA<18)Any significant neurological condition that could impact oropharyngeal activityUse of medications that may impact tone of the upper airway (e.g. hypnotics, opiates) ≥3 nights per week during the 4 weeks prior to randomizationUse of a medical device that would interfere with the use of the home sleep apnea testPlans to move to another city during the study that would impact compliance.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05678088). StuddyBuddy aggregates publicly available trial information.