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Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease (Go To Sleep)

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ClinicalTrials.gov Identifier: NCT00984308
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : September 1, 2015
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE September 25, 2009
Results First Submitted Date March 31, 2015
Results First Posted Date September 1, 2015
Last Update Posted Date June 14, 2017
Actual Study Start Date  ICMJE December 23, 2008
Actual Primary Completion Date September 30, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • Sleep Apnea Diagnosis Rate [ Time Frame: The entire study period (baseline and up to one-year) ]
    The number of patients with a diagnosis of sleep apnea
  • Hypertension Control [ Time Frame: One year ]
    Medication-Adjusted Systolic Blood Pressure
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
Blood pressure [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT00984308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Sleep Apnea Treatment Rate [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Official Title  ICMJE Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Brief Summary Sleep apnea is common among Veterans with cerebrovascular disease (stroke or transient ischemic attack [TIA]), leads to hypertension, and is associated with recurrent stroke and death. Although continuous positive airway pressure (CPAP) safely treats sleep apnea, few Veterans with cerebrovascular disease are diagnosed with sleep apnea or offered treatment.
Detailed Description The project sought to evaluate whether a diagnostic and therapeutic intervention strategy among Veterans with cerebrovascular disease and hypertension using unattended polysomnography and auto-titrating CPAP with a targeted adherence evaluation and educational protocol resulted in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and improved blood pressure control.
Study Type  ICMJE Interventional
Study Phase Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Stroke
  • Transient Ischemic Attack
  • Hypertension
Intervention  ICMJE Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
Study Arms
  • Experimental: Intervention
    The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
    Intervention: Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
  • Control
    The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
    Intervention: Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2011)
225
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
334
Actual Study Completion Date September 30, 2011
Actual Primary Completion Date September 30, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Stroke or Transient Ischemic Attack Hypertension

Exclusion Criteria:

  • Prior diagnosis of sleep apnea or other sleep disorder
  • Life expectancy < 6 months or Hospice
  • Non-English speaker
  • Unable/unwilling to use mask
  • Inability to give informed consent
  • Oxygen dependent COPD
  • Chronic renal failure with dialysis
  • Active Suicidal Ideation
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers 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 NCT00984308
Other Study ID Numbers  ICMJE IIR 06-233
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn M. Bravata, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
PRS Account VA Office of Research and Development
Verification Date May 2017

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