Oropharyngeal Exercises to Treat Obstructive Sleep Apnea
NCT ID: NCT05678088
Last Updated: 2025-05-15
Study Results
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Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-03-28
2026-03-31
Brief Summary
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* 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.
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Detailed Description
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Obstructive sleep apnea (OSA) is a common disorder, and it is estimated that approximately one third of adult Canadians are at risk for obstructive sleep apnea (OSA), and approximately 20% of the general population has been diagnosed with OSA. Few effective treatment options are available to individuals with OSA. Continuous positive airway pressure (CPAP) is first-line therapy for treating moderate to severe OSA, and acts as a pneumatic splint to keep the airway open during sleep. Although CPAP is generally effective at treating OSA, it remains poorly tolerated by many patients; rates of non-adherence are estimated to be as high as 46 to 83%, with only one third of patients using CPAP at 4 years.
Oropharyngeal exercises (OPEs) are commonly used by speech-language pathologists to improve oro-motor strength and range of motion and serve as a promising alternative approach to treat OSA. Studies conducted so far have demonstrated that oropharyngeal exercises may be beneficial in the treatment of OSA. However, two recent systematic reviews concluded that the quality of the available evidence was low and larger blinded studies were needed.
2. RATIONALE
Due to poor rates of adherence, there is a major clinical need to develop alternative treatments to CPAP for OSA that are effective and well-tolerated. While oropharyngeal exercises appear to be a highly promising alternative approach to treat OSA, their efficacy in reducing OSA severity has not been established, and feasibility of this approach has not been demonstrated.
3. STUDY GOALS
Research Question: Is a randomized controlled trial (RCT) of an oropharyngeal exercise regimen in patients with OSA feasible?
Primary Objective: The investigators will determine the feasibility of a randomized controlled trial of an oropharyngeal exercise regimen (involving supervised vs. unsupervised exercises) in patients with moderate to severe OSA who cannot tolerate or are unwilling to use CPAP. The investigators will assess the following: (i) rate of recruitment (ii) adherence to the study exercise intervention. (iii) Ability to ascertain OSA severity (which will be the primary outcome for the full trial).
Secondary Objectives: The investigators will secondarily obtain refined estimates of variability around OSA severity, daytime sleepiness, sleep quality, mood, workplace performance, and quality of life. This will help refine the sample size estimate for the subsequent trial. Furthermore, the investigators will assess the acceptability, appropriateness, and feasibility of the intervention from the perspective of the participants.
4. SIGNIFICANCE
Untreated OSA is a hidden healthcare crisis associated with numerous adverse health and economic consequences. If oropharyngeal exercises are found to be efficacious for the management of OSA, this would provide a novel low-cost, non-pharmacological treatment for OSA that could address current undertreatment due to socioeconomic factors and poor patient tolerance. The proposed feasibility study is the first step to demonstrating potential efficacy of this intervention in the future.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Oropharyngeal Exercises
The participant will practice exercises designed to strengthen the tongue and pharyngeal muscles
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.
Oropharyngeal Exercises
The participant will practice exercises designed to strengthen the tongue and pharyngeal muscles
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.
Sham Exercises
The participant will practice exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength.
Interventions
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Oropharyngeal Exercises
The participant will practice exercises designed to strengthen the tongue and pharyngeal muscles
Sham Exercises
The participant will practice exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Mark Boulos, MD
Principal Investigator
Principal Investigators
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Mark Boulos, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
Hsu B, Emperumal CP, Grbach VX, Padilla M, Enciso R. Effects of respiratory muscle therapy on obstructive sleep apnea: a systematic review and meta-analysis. J Clin Sleep Med. 2020 May 15;16(5):785-801. doi: 10.5664/jcsm.8318. Epub 2020 Feb 6.
Rueda JR, Mugueta-Aguinaga I, Vilaro J, Rueda-Etxebarria M. Myofunctional therapy (oropharyngeal exercises) for obstructive sleep apnoea. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD013449. doi: 10.1002/14651858.CD013449.pub2.
Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11.
Other Identifiers
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5541
Identifier Type: -
Identifier Source: org_study_id
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