Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-23

Study Completion Date

2011-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Stroke Transient Ischemic Attack Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed

Group Type EXPERIMENTAL

CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

Intervention Type PROCEDURE

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

Control

The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services

Group Type OTHER

CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

Intervention Type PROCEDURE

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

Interventions

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CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No