Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Sham Exercises; Behavioral: Oropharyngeal Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05678088

5541

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Supervised Oropharyngeal Exercises

Experimental group

Description:

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.

Treatment:

Behavioral: Oropharyngeal Exercises

Unsupervised Oropharyngeal Exercises

Active Comparator group

Description:

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.

Treatment:

Behavioral: Oropharyngeal Exercises

Supervised Sham Exercises

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham Exercises