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Phase 3 N=225 Randomized Treatment

Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Obstructive Sleep Apnea · Stroke · Transient Ischemic Attack · Hypertension

Enrolled (actual)
225
Serious AEs
3.1%
Results posted
Sep 2015
Primary outcome: Primary: Sleep Apnea Diagnosis Rate — 58; 5 participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA) (Procedure)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Sep 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Sleep Apnea Diagnosis Rate
58; 5
PRIMARY
Hypertension Control
157.4; 161.6
SECONDARY
Sleep Apnea Treatment Rate
22; 0

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00984308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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