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Clinical Trials/NCT00984308
NCT00984308
Completed
Phase 2

Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

VA Office of Research and Development2 sites in 1 country225 target enrollmentDecember 23, 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
VA Office of Research and Development
Enrollment
225
Locations
2
Primary Endpoint
Sleep Apnea Diagnosis Rate
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 23, 2008
End Date
September 30, 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Sleep Apnea Treatment Rate(One year)

Study Sites (2)

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