Sleep Apnea Treatment After Stroke (SATS)

Phase 2

Terminated

• Conditions: Obstructive Sleep Apnea; Stroke
• Interventions: Device: continuous positive airway pressure or CPAP; Device: sham CPAP

• Registration Number: NCT00282815
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-06-21
• Status Verified: 2012-12
• Results First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Results First Posted: 2013-03-11
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	continuous positive airway pressure or CPAP	CPAP
2	sham CPAP	sham CPAP (placebo)

Primary Outcome Measures

Name	Time	Method
Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.	3 months
Number of Subjects Who Withdraw From Study.	3 months	Prespecified outcome.

Secondary Outcome Measures

Name	Time	Method
Barthel Index	3 months	Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States