Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678088
• Other study ID #: 5541
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Mark Boulos, MD, MSc
• Phone: 416-480-4473
• Email: mark.boulos[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Baseline to 10 weeks (post-training) and 14 weeks (retention)
Secondary	Change in Lowest Oxygen Desaturation	Lowest oxygen desaturation will be measured using a home sleep monitor.	Baseline to 10 weeks (post-training) and 14 weeks (retention)
Secondary	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).	Baseline to 10 weeks (post-training) and 14 weeks (retention)
Secondary	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.	Baseline to 10 weeks (post-training) and 14 weeks (retention)
Secondary	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.	Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Secondary	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).	Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Secondary	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.	Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Secondary	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.	Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Secondary	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.	Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Secondary	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.	Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention)
Secondary	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.	10 weeks