Obstructive Sleep ApneaNCT05678088

Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

A study testing Oropharyngeal Exercises in people with Obstructive Sleep Apnea, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Oropharyngeal Exercises
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteCanada
Study dates: 28 Mar 2023to Mar 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

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

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.

Read the detailed description

BACKGROUND 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.
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.
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.
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: Obstructive Sleep Apnea
Being tested: Oropharyngeal Exercises, Sham Exercises
Keywords: Obstructive Sleep Apnea, Oropharyngeal Exercises
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oropharyngeal ExercisesBehavioural
The participant will practice exercises designed to strengthen the tongue and pharyngeal muscles
Sham ExercisesBehavioural
The participant will practice exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength.

Study groups in NCT05678088
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Sham Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 14 weeks

Secondary outcomes (11)

Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index)
Measured by the apnea-hypopnea index (AHI). AHI quantifies the number of apneas and hypopneas per hour of sleep. It will be measured using a home sleep monitor.
Measured: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Lowest Oxygen Desaturation
Lowest oxygen desaturation will be measured using a home sleep monitor.
Measured: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Objective sleep quality
Objective sleep quality and quantity will be assessed using wrist actigraphy that will be provided with the home sleep apnea test. Sleep efficiency will be calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes).
Measured: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Objective sleep quantity
Objective sleep quality will be assessed using wrist actigraphy that will be provided with the home sleep apnea test. The total sleep time will be calculated.
Measured: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Sleep Quality (as assessed by the Pittsburgh Sleep Quality Index)
Sleep quality as assessed by the Pittsburgh Sleep Quality Index. The questionnaire is scored on a range from 0-21 points, with "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Measured: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).
Measured: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Mood (as assessed by the Beck Depression Inventory)
The Beck Depression Inventory has 21 questions that are scored on a range of 0-63 points. Higher scores indicate more severe depression.
Measured: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Workplace performance (as assessed by the Work Limitations Questionnaire)
Workplace performance as assessed by the Work Limitations Questionnaire. There are 25 items, that address 4 scales: Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.
Measured: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Self-reported Quality of Life as assessed by the EQ-5D-5L
The EQ-5D-5L questionnaire has 5 dimensions: Mobility, Self-Care, Usual Activity, Pain/Discomfort, Anxiety/Depression, with each dimension rated on a level from 1-5 where higher scores indicate more severe problems.
Measured: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Self-reported Quality of Life (as assessed by the SF-36 Questionnaire)
The SF-36 Questionnaire has 36-items that covers eight areas: physical functioning, bodily pai, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score indicating better health.
Measured: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Acceptability, Appropriateness, and Feasibility of Intervention Measure
Acceptability, Appropriateness, and Feasibility of Intervention Measure Questionnaire contains 4 questions for each dimension (acceptability, appropriateness, and feasibility). Each question is rated from 1-5, and higher scores indicate that participants believe this is a more acceptable, appropriate, or feasibly intervention.
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 2023Mar 2027

First posted10 Jan 2023
Study start28 Mar 2023
Primary completionDec 2026 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05678088
Sponsor's protocol ID: 5541
Status last verified: Aug 2026
First submitted: 15 Dec 2022
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19960649
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.
PubMed 18250209
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.
PubMed 32026802
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.
PubMed 33141943
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.
PubMed 26380759

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Strengthening Oropharyngeal Muscles as a Novel Approach to Treat Obstructive Sleep Apnea: A Randomized Feasibility Study
ClinicalTrials.gov ID: NCT05678088
Acronym / sponsor ID: 5541
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea, Oropharyngeal Exercises
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 45 participants (estimated)
Lead sponsor: Sunnybrook Health Sciences CentreUniversity, hospital or other
Study start: 28 Mar 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 10 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

BACKGROUND 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.
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.
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.
SIGNIFICANCE

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Supervised Oropharyngeal Exercises	Experimental	Behavioral: Oropharyngeal ExercisesThe 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.
Unsupervised Oropharyngeal Exercises	Active comparator	Behavioral: Oropharyngeal ExercisesThe 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.
Supervised Sham Exercises	Sham comparator	Behavioral: Sham ExercisesThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oropharyngeal ExercisesThe participant will practice exercises designed to strengthen the tongue and pharyngeal muscles	Behavioural	Supervised Oropharyngeal Exercises, Unsupervised Oropharyngeal Exercises
Sham ExercisesThe participant will practice exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength.	Behavioural	Supervised Sham Exercises

Primary outcome

Rate of recruitment
Time frame: 2 years
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
Patient adherence with the study exercises
Time frame: 10 weeks
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.
Ability to ascertain Obstructive Sleep Apnea (OSA) severity
Time frame: 14 weeks
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.

11 secondary outcomes

Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index)
Time frame: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Lowest Oxygen Desaturation
Time frame: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Objective sleep quality
Time frame: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Objective sleep quantity
Time frame: Baseline to 10 weeks (post-training) and 14 weeks (retention)
Change in Sleep Quality (as assessed by the Pittsburgh Sleep Quality Index)
Time frame: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Time frame: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Mood (as assessed by the Beck Depression Inventory)
Time frame: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Workplace performance (as assessed by the Work Limitations Questionnaire)
Time frame: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Self-reported Quality of Life as assessed by the EQ-5D-5L
Time frame: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Change in Self-reported Quality of Life (as assessed by the SF-36 Questionnaire)
Time frame: Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Acceptability, Appropriateness, and Feasibility of Intervention Measure
Time frame: 10 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Background: PubMed 19960649Epstein 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.
Background: PubMed 18250209Weaver 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.
Background: PubMed 32026802Hsu 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.
Background: PubMed 33141943Rueda 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.
Background: PubMed 26380759Franklin 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Boulos, MD, MSc principal investigator

Sunnybrook Health Sciences Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oropharyngeal Exercises in people with Obstructive Sleep Apnea, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of recruitment (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678088, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.