Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

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.

• 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]