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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
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Stroke
Device: continuous positive airway pressure or CPAP
Device: sham CPAP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Obstructive Sleep Apnea After Stroke

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Barthel Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).


Enrollment: 32
Study Start Date: September 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
CPAP
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.
Sham Comparator: 2
sham CPAP (placebo)
Device: sham CPAP
sham CPAP

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282815

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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
  More Information

Publications:
Responsible Party: Devin Brown, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00282815     History of Changes
Other Study ID Numbers: K23NS51202
Study First Received: January 26, 2006
Results First Received: June 21, 2011
Last Updated: January 31, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
obstructive sleep apnea
stroke
OSA
CPAP
continuous positive airway pressure

Additional relevant MeSH terms:
Apnea
Cerebral Infarction
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014