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Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

This study has been terminated.
(problems with recruitment)
Sponsor:
Information provided by (Responsible Party):
Joel E. Dimsdale, M.D., University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00952211
First received: August 3, 2009
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.


Condition Intervention Phase
Stroke
Obstructive Sleep Apnea
 Device: CPAP
Device: CPAP at sub-therapeutic pressure
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • fatigue [ Time Frame: 10 days after beginning CPAP treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 10 days after beginning CPAP treatment ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP
CPAP at therapeutic pressure
 Device: CPAP
CPAP at therapeutic pressure during nighttime
Sham Comparator: sub-therapeutic CPAP
CPAP administered at sub-therapeutic pressure
 Device: CPAP at sub-therapeutic pressure
CPAP delivered at sub-therapeutic pressure at nighttime

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke survivor in stroke rehabilitation unit
  • age 45-85
  • able to consent
  • no prior treatment with CPAP

Exclusion Criteria:

  • complex apnea
  • known inflammatory disease
  • neurological disease precluding patient's ability to consent and cooperate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952211

Locations
United States, California
UCSD
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Joel Dimsdale, MD UCSD
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joel E. Dimsdale, M.D., Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00952211     History of Changes
Other Study ID Numbers: HL091848, HL091848
Study First Received: August 3, 2009
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
stroke
obstructive sleep apnea
fatigue
quality of life

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

ClinicalTrials.gov processed this record on May 21, 2013