NCT04212260

Oropharyngeal Exercises and Post-Stroke Obstructive Sleep Apnea

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study evaluates the feasibility and effectiveness of an oropharyngeal exercise (O-PE) regimen in treating post-stroke obstructive sleep apnea, as an alternative therapy to continuous positive airway pressure (CPAP). Eligible patients will be randomized (1:1) to treatment using a pre-specified schedule of O-PEs vs. a sham control arm.

Detailed description

BACKGROUND Obstructive sleep apnea (OSA) is characterized by recurrent obstruction of the upper airway during sleep due to intermittent loss of pharyngeal dilator muscle tone. OSA is both a risk factor for stroke, as well as a common post-stroke co-morbidity with approximately 72% of patients with stroke or transient ischemic attack (TIA) having OSA. Post-stroke OSA is linked to post-stroke, fatigue, which is a top research priority for stroke patients. Moreover, post-stroke OSA is associated with greater mortality, a higher risk of recurrent stroke, poorer cognition and lower functional status. In addition, stroke patients with OSA spend significantly longer times in rehabilitation and in acute care hospitals. Since OSA has a significant impact on the health of stroke patients, it is imperative that effective treatments are used to assist patients. Continuous positive airway pressure (CPAP) is the gold standard treatment for patients with moderate to severe OSA. However, despite having been demonstrated to improve post-stroke cognition, motor and functional outcomes,and overall quality of life, rates of CPAP adherence are low. Reasons for poor post-stroke CPAP adherence are multi-factorial and often not easily modifiable. Overall, there is a major clinical need to develop an alternative effective and well-tolerated treatment for OSA. Oro-pharyngeal exercises (O-PEs) 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. For example, in a randomized controlled trial in which patients with moderate OSA underwent 3 months of daily exercises focusing on strengthening oro-pharyngeal musculature, OSA severity and symptoms were demonstrated to be significantly reduced compared to sham exercises.Similarly, use of the didgeridoo, a wind instrument that strengthens muscles of the upper airway, has also been demonstrated to reduce OSA severity. METHODS Research Question: Is a randomized controlled trial (RCT) of an O-PE regimen in post-stroke OSA feasible? Primary Objective: To examine whether an RCT of an O-PE regimen is feasible in stroke patients with OSA who are unable to tolerate CPAP. (i) The O-PE regimen will be considered feasible if \>80% of enrolled patients complete \>80% of the study exercises. (ii) We will also track the monthly number of eligible vs. recruited patients from Dr. Boulos' stroke and sleep disorders clinic. Hypothesis: An RCT of an O-PE regimen in post-stroke OSA will be feasible in that \>80% of enrolled patients will complete \>80% of the study exercises. Secondary Objectives: To explore whether an O-PE regimen, compared to sham activities, might be effective in (i) improving various objective sleep metrics (i.e. OSA severity and nocturnal oxygen saturation), (ii) improving various measures of oropharyngeal physiology and function (i.e. oro-pharyngeal deficits and dysarthria, tongue/lip/jaw weakness, and oro-facial kinematics), and (iii) enhancing self-reported sleep-related symptoms. Hypothesis: Compared to the sham activities, O-PEs will positively influence the outcomes noted above.

Conditions

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Transient Ischemic Attack

Interventions

Type	Name	Description
BEHAVIORAL	Oropharyngeal exercises	Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.
BEHAVIORAL	Sham control	Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2019-12-26
• Last updated: 2023-04-14

Locations

1 site across 1 country: Canada