Oropharyngeal Exercises and Post-Stroke Obstructive Sleep Apnea

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04212260

Collaborator

Toronto Rehabilitation Institute (Other), University of Toronto (Other), Unity Health Toronto (Other), Sunnybrook Research Institute (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Stroke Transient Ischemic Attack	Behavioral: Oropharyngeal exercises Behavioral: Sham control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The parties involved consist of patients, sleep medicine team (includes sleep clinician and research personnel who collect/assess sleep data), and speech-language pathology team (research personnel who provide instructions on exercises and collect/assess speech data). All patients and members of the sleep medicine team will be masked to the condition assigned to each patient. The speech-language pathology team is not blinded to the patient assignments.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oro-pharyngeal exercises Use of oro-pharyngeal exercises	Behavioral: Oropharyngeal exercises Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.
Sham Comparator: Sham control Use of sham exercises.	Behavioral: Sham control Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.

Arm

Intervention/Treatment

Experimental: Oro-pharyngeal exercises

Use of oro-pharyngeal exercises

Behavioral: Oropharyngeal exercises

Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.

Sham Comparator: Sham control

Use of sham exercises.

Behavioral: Sham control

Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.

Outcome Measures

Primary Outcome Measures

Percentage of enrolled participants completing >80% of the study exercises [6-10 weeks (post-training)]
The study exercise regimen will be deemed feasible if >80% of enrolled patients complete >80% of the study exercises. Patient adherence with study exercises in both treatment arms will be recorded (in minutes) via use of the App that will deliver the oropharyngeal exercises/sham exercises. Completion of >80% of the study exercises would be indicated by >720 recorded minutes (if post-training visit is after 6 weeks) or >1200 recorded minutes (if post-training visit is after 10 weeks).

Secondary Outcome Measures

OSA severity (as measured by the apnea-hypopnea index) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
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 that has been validated for use in the stroke population.
Lowest oxygen desaturation [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Lowest oxygen desaturation will be measured using a home sleep monitor that has been validated for use in the stroke population.
Oro-pharyngeal deficits and dysarthria (as measured by the second version of Frenchey Dysarthria Assessment) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
The second version of Frenchay Dysarthria Assessment (FDA-2) is divided into 7 sections: reflexes, respiration, lips, palate, laryngeal, tongue, and intelligibility, each containing several individual items. Each item is rated on a scale from "0" to "7", where "0" means normal for age, and "7" means unable to undertake task/movement/sound. The total score of the 7 sections will determine the severity of dysarthria.
Tongue/lip/jaw weakness [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Measured by the Iowa Oral Performance Instrument & Flexiforce (max pressure, endurance)
Oro-facial kinematic capacity [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Oro-facial kinematic capacity is defined by the range of facial motions (in mm) for lips and jaw, assessed during a standardized series of oro-motor tasks (e.g. Maximum mouth opening, syllable repetition)
Functional status (as measured by Functional Outcomes of Sleep Questionnaire) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Functional Outcomes of Sleep Questionnaire (FOSQ) encompasses 5 subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome. An average score is calculated for each subscale and the 5 subscales are totaled to produce a total score. Subscale scores range from 1-4 with total scores ranging from 5-20. Higher scores indicate better functional status.
Daytime sleepiness (as measured by Epworth Sleepiness Scale) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
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).
Fatigue (as measured by Fatigue Severity Scale) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.
Quality of Life (as measured by Stroke Impact Scale) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Stroke Impact Scale (SIS) assesses multidimensional stroke outcomes through 8 domains: strength (raw score range: 4-20), hand function (5-25), activities of daily living (score range 10-50), mobility (score range 9-45), communication (score range 7-35), emotion (score range 9-45), memory and thinking (score range: 7-35), and participation (8-40). Each domain is scored separately. For each domain, raw scores are transformed using the following formula: Transformed Scale = (Actual raw score - lowest possible raw score)*100 / (Possible raw score range). Higher scores indicate greater quality of life.
Cognitive ability (as measured by Montreal Cognitive Assessment) [Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)]
Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment. Scores range from 0 to 30, with higher scores indicating greater cognitive ability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Imaging-confirmed stroke or stroke specialist-diagnosed transient ischemic attack (TIA)
Prior diagnosis of OSA by a physician at any time in the past.
Unable to tolerate CPAP after a 2-week trial of CPAP

Exclusion Criteria:

BMI > 40 kg/m2
The presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure.
Oxygen therapy (e.g. nasal prongs), a nasogastric tube, or other medical device that would interfere with the placement of the home sleep apnea test
Cranial malformations/nasal obstruction
Significant depressive symptoms
Regular use of hypnotic medications
Other neuromuscular diseases or conditions affecting oropharyngeal muscles
Montreal Cognitive Assessment (MoCA) < 18
Aphasia
Oral or apraxia of speech

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre
Toronto Rehabilitation Institute
University of Toronto
Unity Health Toronto
Sunnybrook Research Institute

Investigators

Principal Investigator: Mark Boulos, MD MSc FRCPC, Sunnybrook Health Sciences Centre
Principal Investigator: Yana Yunusova, MSc PhD, Sunnybrook Health Sciences Centre