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Sleep Apnea Treatment After Stroke (SATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 26, 2006
First Posted Date  ICMJE January 27, 2006
Results First Submitted Date  ICMJE June 21, 2011
Results First Posted Date  ICMJE March 11, 2013
Last Update Posted Date March 11, 2013
Study Start Date  ICMJE September 2004
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2006)
(1) Hours of treatment use per week (2) number of subjects who withdraw from study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
Barthel Index [ Time Frame: 3 months ]
Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2006)
Secondary outcome measures include functional outcome, depression, fatigue, and sleepiness.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Apnea Treatment After Stroke (SATS)
Official Title  ICMJE Treatment of Obstructive Sleep Apnea After Stroke
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Stroke
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    CPAP
    Intervention: Device: continuous positive airway pressure or CPAP
  • Sham Comparator: 2
    sham CPAP (placebo)
    Intervention: Device: sham CPAP
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 31, 2013)
32
Original Enrollment  ICMJE
 (submitted: January 26, 2006)
200
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282815
Other Study ID Numbers  ICMJE K23NS051202( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Devin Brown, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Michigan
Verification Date December 2012

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