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

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VA Office of Research and Development

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hypertension
Stroke
Transient Ischemic Attack
Obstructive Sleep Apnea

Treatments

Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00984308
IIR 06-233

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

225 participants in 2 patient groups

Intervention
Experimental group
Description:
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
Treatment:
Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)
Control
Other group
Description:
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
Treatment:
Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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