Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00984308
First received: September 24, 2009
Last updated: October 30, 2014
Last verified: October 2014

September 24, 2009
October 30, 2014
December 2008
September 2011   (final data collection date for primary outcome measure)
  • Sleep apnea diagnosis rate [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Hypertension control [ Time Frame: One year ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: One year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984308 on ClinicalTrials.gov Archive Site
Sleep apnea treatment rate [ Time Frame: One year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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: Arm 1
    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)
  • Arm 2
    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 2011
September 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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984308
IIR 06-233
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Dawn M. Bravata, MD Richard Roudebush VA Medical Center, Indianapolis
Department of Veterans Affairs
October 2014

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