Stroke Clinical Trial
Official title:
Treatment of Obstructive Sleep Apnea After Stroke
The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.
Stroke is the leading cause of adult disability in the United States, yet there are very few
treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway
blockage that occurs during sleep--is common after stroke, affecting more than half of
stroke patients. The most common treatment for obstructive sleep apnea in the general
population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask
during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open
during sleep.
The objective of this single-center, prospective, randomized study is to evaluate CPAP
treatment in post-stroke patients. Participants will go through a medical interview, a brief
neurological examination, and a sleep study to screen them for OSA. Those with OSA will be
eligible for the second phase of the study during which participants will be randomly
selected to receive either treatment with CPAP or with sham CPAP (placebo).
This project promises to establish feasibility, develop design and identify suitable outcome
measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue,
and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with
OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all
stroke patients will become available.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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