Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease

Phase 2

Completed

• Conditions: Stroke; Obstructive Sleep Apnea; Transient Ischemic Attack; Hypertension
• Interventions: Procedure: CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA)

• Registration Number: NCT00984308
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-12-23
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Results First Submitted: 2015-03-31
• Results First Submitted QC: 2015-08-10
• Results First Posted: 2015-09-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sleep Apnea Diagnosis Rate	The entire study period (baseline and up to one-year)	The number of patients with a diagnosis of sleep apnea
Hypertension Control	One year	Medication-Adjusted Systolic Blood Pressure

Secondary Outcome Measures

Name	Time	Method
Sleep Apnea Treatment Rate	One year

Trial Locations

Locations (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

Richard L. Roudebush VA Medical Center, Indianapolis, IN; 🇺🇸 Indianapolis, Indiana, United States