Sleep Apnea Treatment After Stroke (SATS)

NCT ID: NCT00282815

Last Updated: 2013-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-05-31

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.

Conditions

Obstructive Sleep Apnea; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

CPAP

Group Type: ACTIVE_COMPARATOR

continuous positive airway pressure or CPAP

Intervention Type: DEVICE

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.

2

sham CPAP (placebo)

Group Type: SHAM_COMPARATOR

sham CPAP

Intervention Type: DEVICE

sham CPAP

Interventions

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.

Intervention Type: DEVICE

sham CPAP

sham CPAP

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Devin Brown

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devin Brown, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Stroke Program, University of Michigan

Lewis Morgenstern, MD

Role: STUDY_DIRECTOR

Director, Stroke Program, University of Michigan

Jack Kalbfleisch, PhD

Role: STUDY_DIRECTOR

University of Michigan Dept of Biostatistics

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21784661 (View on PubMed)

Other Identifiers

K23NS051202

Identifier Type: NIH

Identifier Source: org_study_id

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