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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00984308
First received: September 24, 2009
Last updated: May 15, 2017
Last verified: May 2017
September 24, 2009
May 15, 2017
December 23, 2008
September 30, 2011   (Final data collection date for primary outcome measure)
  • 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
Blood pressure [ Time Frame: One year ]
Complete list of historical versions of study NCT00984308 on ClinicalTrials.gov Archive Site
Sleep Apnea Treatment Rate [ Time Frame: One year ]
Not Provided
Not Provided
Not Provided
 
Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Stroke
  • Transient Ischemic Attack
  • Hypertension
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.
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
September 30, 2011
September 30, 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00984308
IIR 06-233
Yes
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
Undecided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Dawn M. Bravata, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
VA Office of Research and Development
May 2017

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