Clinical trial NCT00282815: Sleep Apnea Treatment After Stroke (SATS)
Official title: Treatment of Obstructive Sleep Apnea After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Stroke
Keywords: obstructive sleep apnea
stroke
OSA
CPAP
continuous positive airway pressure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2006-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke within 7 days of planned polysomnography/sleep screening study
* Modified Rankin Scale score \>1
* If of child-bearing potential, has a negative urine or serum pregnancy test

Exclusion Criteria:

* Decompensated heart failure
* Cardiac or respiratory arrest within the past 3 months
* Myocardial infarction within the past 3 months
* Severe pneumonia
* Hypertension refractory to treatment
* Any other unstable medical condition which is thought to interfere with participation
* Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP
* Previous pneumothorax
* Bullous emphysema
* Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP
* Acute sinus or ear infection

Primary outcomes:
measure: Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.
timeFrame: 3 months
measure: Number of Subjects Who Withdraw From Study.
timeFrame: 3 months
Secondary outcomes:
measure: Barthel Index
timeFrame: 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor, Stroke Program, University of Michigan
name: Devin Brown, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Director, Stroke Program, University of Michigan
name: Lewis Morgenstern, MD
role: STUDY_DIRECTOR
affiliation: University of Michigan Dept of Biostatistics
name: Jack Kalbfleisch, PhD
role: STUDY_DIRECTOR
References:
citation: Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016/j.jstrokecerebrovasdis.2011.06.010. Epub 2011 Jul 23.