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OpenTrials
Completed

NCT Number: NCT00984308

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Hypertension Ischemic Attack, Transient Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Transient Ischemic Attack Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

Procedure

Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.

Primary outcomes

  1. 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

  2. Hypertension Control

    Time frame: One year

    Medication-Adjusted Systolic Blood Pressure

Secondary outcomes

  1. Sleep Apnea Treatment Rate

    Time frame: One year

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: Go To Sleep

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2009
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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