Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease "Go To Sleep"

Completed

Phase 2/3 Results

Trial Description

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.

Conditions

Interventions

  • CPAP Therapy for Newly Diagnosed Obstructive Sleep Apnea (OSA) Procedure
    Intervention Desc: Continuous Positive Airway Pressure (CPAP) is provided for those patients who are diagnosed with OSA.
    ARM 1: Kind: Experimental
    Label: 1
    Description: We offer treatment for sleep apnea with an anticipated outcome of reduction of ambulatory blood pressures.
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
    ARM 3: Kind: Experimental
    Label: Arm 2
    Description: The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
    ARM 4: Kind: Experimental
    Label: Intervention
    Description: The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
    ARM 5: Kind: Experimental
    Label: Control
    Description: The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
  • CPAP Treatment Device
    Other Names: Continuous Positive Airway Pressure
    Intervention Desc: Patients will receive auto-titrating CPAP treatment for one year. This includes an intensive in-person patient contact CPAP adherence/educational protocol during the first two months following enrollment.
    ARM 1: Kind: Experimental
    Label: 1.CPAP Treatment
    Description: Patients randomized to the intervention arm who are diagnosed with obstructive sleep apnea will be offered auto-titrating CPAP treatment for one year. This includes an intensive initial in-person patient contact adherence/educational protocol during the first two months of CPAP treatment.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary outcome measure is the proportion of patients with a diagnosis of sleep apnea in both arms (where the denominator is all patients randomized to each arm). 1 year post enrollment No
Secondary The blood pressure outcome for this study is the mean 24-hour ambulatory systolic pressure obtained at one-year post enrollment one year post enrollment No
Primary Mean 24-hour systolic blood pressure One year No
Secondary Rate of sleep apnea diagnosis One year No
Secondary Rate of sleep apnea treatment One year No
Primary Sleep apnea diagnosis rate One year No
Secondary Sleep apnea treatment rate One year No
Primary Hypertension control One year No

Sponsors