Sleep Apnea Treatment After Stroke (SATS)
|ClinicalTrials.gov Identifier: NCT00282815|
Recruitment Status : Terminated (Poor recruitment. Funding expired.)
First Posted : January 27, 2006
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Stroke||Device: continuous positive airway pressure or CPAP Device: sham CPAP||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Obstructive Sleep Apnea After Stroke|
|Study Start Date :||September 2004|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Active Comparator: 1
Device: continuous positive airway pressure or CPAP
RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
Sham Comparator: 2
sham CPAP (placebo)
Device: sham CPAP
- Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. [ Time Frame: 3 months ]
- Number of Subjects Who Withdraw From Study. [ Time Frame: 3 months ]Prespecified outcome.
- Barthel Index [ Time Frame: 3 months ]Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282815
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Devin Brown, MD, MS||Associate Professor, Stroke Program, University of Michigan|
|Study Director:||Lewis Morgenstern, MD||Director, Stroke Program, University of Michigan|
|Study Director:||Jack Kalbfleisch, PhD||University of Michigan Dept of Biostatistics|