Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

NCT05678088 | Recruiting

• 1 other identifier: 5541
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Oropharyngeal Exercises

Outcome Measures

Primary Outcomes (3)

• Rate of recruitment

  The study team will maintain logs to track the number of patients screened, found to be eligible, and randomized into the trial; we will also track dropouts

  2 years

• Patient adherence with the study exercises

  Patient adherence with the study exercises will be tracked (in minutes) by the OPEX app that will deliver the oropharyngeal/sham exercises. We will compute the percentage of exercises completed.

  10 weeks

• Ability to ascertain Obstructive Sleep Apnea (OSA) severity

  Ability to ascertain OSA severity, as assessed by completion rates for the three home sleep apnea tests at baseline, post-training and retention. A home sleep apnea test will be considered "completed" if ≥4 hours of flow, effort, and oxygen evaluation are obtained. The cut-off of ≥4 hours was selected as it has been recommended by clinical practice guidelines and previously used in prior home sleep apnea test feasibility studies.

  14 weeks

Secondary Outcomes (11)

• Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index)

  Baseline to 10 weeks (post-training) and 14 weeks (retention)

• Change in Lowest Oxygen Desaturation

  Baseline to 10 weeks (post-training) and 14 weeks (retention)

• Change in Objective sleep quality

  Baseline to 10 weeks (post-training) and 14 weeks (retention)

• Change in Objective sleep quantity

  Baseline to 10 weeks (post-training) and 14 weeks (retention)

• Change in Sleep Quality (as assessed by the Pittsburgh Sleep Quality Index)

  Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)

Study Arms (3)

Supervised Oropharyngeal Exercises

EXPERIMENTAL

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.

Behavioral: Oropharyngeal Exercises

Unsupervised Oropharyngeal Exercises

ACTIVE COMPARATOR

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.

Behavioral: Oropharyngeal Exercises

Supervised Sham Exercises

SHAM COMPARATOR

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.

Behavioral: Sham Exercises

Interventions

Oropharyngeal Exercises BEHAVIORAL

The participant will practice exercises designed to strengthen the tongue and pharyngeal muscles

Supervised Oropharyngeal Exercises; Unsupervised Oropharyngeal Exercises

Sham Exercises BEHAVIORAL

The participant will practice exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength.

Supervised Sham Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 19960649 BACKGROUND

• 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.

  PMID: 18250209 BACKGROUND

• 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.

  PMID: 32026802 BACKGROUND

• 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.

  PMID: 33141943 BACKGROUND

• 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.

  PMID: 26380759 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mark Boulos, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Boulos, MD, MSc

CONTACT

416-480-4473; mark.boulos@sunnybrook.ca

Sarah Berger, MSc

CONTACT

sarah.berger@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 10, 2023
• Study Start: March 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)