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Sleep Apnea Treatment After Stroke (SATS)

This study has been terminated.
(Poor recruitment. Funding expired.)
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan
ClinicalTrials.gov Identifier:
NCT00282815
First received: January 26, 2006
Last updated: January 31, 2013
Last verified: December 2012

January 26, 2006
January 31, 2013
September 2004
May 2010   (final data collection date for primary outcome measure)
  • Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of Subjects Who Withdraw From Study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Prespecified outcome.
(1) Hours of treatment use per week (2) number of subjects who withdraw from study.
Complete list of historical versions of study NCT00282815 on ClinicalTrials.gov Archive Site
Barthel Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).
Secondary outcome measures include functional outcome, depression, fatigue, and sleepiness.
Not Provided
Not Provided
 
Sleep Apnea Treatment After Stroke (SATS)
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Stroke
  • 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.
  • Device: sham CPAP
    sham CPAP
  • Active Comparator: 1
    CPAP
    Intervention: Device: continuous positive airway pressure or CPAP
  • Sham Comparator: 2
    sham CPAP (placebo)
    Intervention: Device: sham CPAP
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. 2011 Jul 22. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00282815
K23NS51202
No
Devin Brown, University of Michigan
University of Michigan
Not Provided
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
University of Michigan
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP