Positional Therapy to Treat Obstructive Sleep Apnea in Stroke Patients: A Randomized Controlled
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change in obstructive sleep apnea severity (Apnea-hypopnea index)
Study Overview
Brief Summary
Obstructive sleep apnea (OSA) has been found to be very common in stroke patients. Obstructive sleep apnea has been found to impede stroke rehabilitation and recovery. However, currently, there are few treatment options for OSA in stroke patients. Continuous positive airway pressure (CPAP) is the current therapy commonly used for OSA in the general population, however stroke patients are not highly compliant with this device. Therefore, we have decided to propose a more feasible alternative to treating obstructive sleep apnea through positional therapy. Positional therapy involves using a device to prevent patients from sleeping on their backs, since this position has been found to exacerbate obstructive sleep apnea. Therefore, we hypothesize that stroke patients who use the positional therapy belt will experience improvements in the severity of OSA.
Detailed Description
- BACKGROUND
Obstructive sleep apnea is very common in stroke patients, with reported prevalence rates between 30% and 70%. Recent studies suggest that it represents both a risk factor and a consequence of stroke and affects stroke recovery, outcome, and recurrence. A case-control study found that stroke patients with OSA had worse neurological status, lower functional independence scores, and a longer period of hospitalization than stroke patients without OSA. Furthermore, leaving OSA untreated after stroke affects rehabilitation efforts and short- and long-term stroke recovery and outcomes. Current literature supports the implementation of treatment protocols for OSA post-stroke in stroke units. This warrants the need to improve treatment of OSA in stroke patients as a means of secondary prevention and improvement of stroke outcomes.
1.1 Treating OSA in stroke patients
Continuous positive airway pressure (CPAP) is the current gold standard therapy for OSA in the general population. Early CPAP therapy was found to have a positive effect on long-term survival in ischaemic stroke patients with moderate-severe OSA. However, CPAP is generally poorly tolerated by stroke patients and has a low compliance. Another alternative therapy, nasal expiratory positive airway pressure (EPAP), was also found to be an ineffective alternative to CPAP in acute stroke patients with OSA.
Since sleeping in the supine position increases the chance of sleep apnea due to the tendency of the tongue to fall back and block the pharyngeal airway, having stroke patients sleep in a lateral position may improve OSA severity. As sleeping in the supine position is very common in acute stroke patients, positional therapy that reduces supine sleep may be beneficial in treating OSA in stroke patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute ischemic stroke
- •Patient has been treated at Sunnybrook Health Sciences Centre
Exclusion Criteria
- •Patients who are unable to lie in a supine position (can be due to existing medical conditions)
- •Patients who are using positive airway pressure therapy or supplemental oxygen at the time of the study
- •Patients who are unable to use the portable sleep monitoring device
- •Physical impairment, aphasia, language barrier, facial/bulbar weakness or trauma restricting the ability to use the portable sleep monitor, and absence of caregiver who can provide assistance
- •Women who are pregnant during the study period
Arms & Interventions
Positional Therapy Belt
Use of positional therapy belt (SlumberBUMP) during sleep.
Intervention: Positional therapy belt (Device)
Standard Care
No positional therapy belt provided for use during sleep.
Outcomes
Primary Outcomes
Change in obstructive sleep apnea severity (Apnea-hypopnea index)
Time Frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Apnea-hypopnea index will be measured using the Resmed ApneaLink device
Change in obstructive sleep apnea severity (oxygen desaturation)
Time Frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Oxygen desaturation will be measured using the Resmed ApneaLink device
Secondary Outcomes
- Change in sleep efficiency (actigraphy)(Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline))
- Change in neurological outcomes (Montreal Cognitive Assessment)(Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline))
- Change in psychological outcomes (Centre for Epidemiological Studies Depression Scale)(Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline))
- Change in quality of life (SF-12 quality of life questionnaire)(Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline))
- Change in time spent in the supine position during sleep(Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline))
- Change in neurological outcomes (National Institutes of Health Stroke Scale)(Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline))
- Hospital length of stay(Within 3-6 months of baseline)
- Change in reaction time (psychomotor vigilance test)(Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline))
- Change in daytime sleepiness (Epworth sleepiness scale)(Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline))
- Change in neurological outcomes (Modified Rankin scale)(Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline))
- Change in performance in activities of daily living (Barthel Index)(Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline))
Investigators
Dr. Mark Boulos
Principal Investigator
Sunnybrook Health Sciences Centre