Using oropharyngeal exercises to treat obstructive sleep apnea
Strengthening Oropharyngeal Muscles as a Novel Approach to Treat Obstructive Sleep Apnea: A Randomized Feasibility Study
This study is testing if doing oropharyngeal exercises using an app can help people with obstructive sleep apnea improve their sleep and overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05678088 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using oropharyngeal exercises (OPEs) as a treatment for obstructive sleep apnea (OSA). Participants will be randomized into three groups: a supervised OPE intervention, an unsupervised OPE intervention, and a sham treatment, with a protocol involving two 20-minute sessions per week for 10 weeks. The study will assess the impact of these exercises on sleep apnea severity, daytime sleepiness, sleep quality, mood, workplace performance, and overall quality of life. The exercises will be administered through an app, making it accessible for participants.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with obstructive sleep apnea who are unwilling or unable to tolerate CPAP therapy.
Not a fit: Patients who are currently using CPAP or other equipment-based treatments for OSA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a well-tolerated alternative treatment for patients who struggle with CPAP therapy.
How similar studies have performed: Previous studies have suggested potential benefits of oropharyngeal exercises for OSA, but larger, blinded studies are needed to confirm their efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mark Boulos, MD, MSc — Sunnybrook Health Sciences Centre
- Study coordinator: Mark Boulos, MD, MSc
- Email: mark.boulos@sunnybrook.ca
- Phone: 416-480-4473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.