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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):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00984308
First received: September 24, 2009
Last updated: April 18, 2013
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Stroke
Transient Ischemic Attack
Hypertension
 Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Sleep apnea diagnosis rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep apnea treatment rate [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Rate of sleep apnea treatment [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: December 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
 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.
Arm 2
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
 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.

Detailed Description:

The project seeks 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 results in: an improved rate of diagnosed sleep apnea, an improved rate of treated sleep apnea, and lowered mean 24-hour systolic blood pressure. Secondary aims include: to determine whether the intervention strategy reduces the number of antihypertensive medications; to collect data supporting a cost-effectiveness evaluation if the intervention strategy is effective; and to determine whether the intervention strategy reduces daytime sleepiness.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984308

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Indiana
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Dawn M. Bravata, MD Richard Roudebush VA Medical Center, Indianapolis
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00984308     History of Changes
Obsolete Identifiers: NCT00807417
Other Study ID Numbers: IIR 06-233
Study First Received: September 24, 2009
Last Updated: April 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
sleep apnea
hypertension
brain ischemia

Additional relevant MeSH terms:
Apnea
Ischemic Attack, Transient
Cerebrovascular Disorders
Hypertension
Sleep Apnea Syndromes
Stroke
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Brain Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on May 23, 2013