Burden of Obstructive Sleep Apnea in Stroke (BOSAST) "BOSAST"

Terminated

Phase 4 Results

Trial Description

There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.

Detailed Description

Stroke survivors frequently complain of fatigue, depressive symptoms, and decreased cognitive functioning. These burdens complicate the recovery and rehabilitation from stroke. While there may be many contributing factors to these burdens, one factor in particular may be both terribly common and yet readily susceptible to intervention. Consistent reports from around the world demonstrate that >50% of stroke patients have obstructive sleep apnea (OSA), a disorder that is also associated with fatigue, depressive symptoms, and decreased cognitive functioning. OSA is also associated with increases in inflammatory products which themselves are associated with the same array of burdens.
This study will examine inpatients at a stroke rehabilitation center. Patients' sleep will be studied. Patients with OSA will be randomized to 10 days treatment double blind with either continuous positive airways pressure (CPAP) treatment or to sub-therapeutic CPAP treatment. After 10 days of treatment, the OSA patients and the stroke patient without OSA will be restudied.
The study will shed light on the impact of OSA on stroke patients' burdens.

Trial Stopped: problems with recruitment

Conditions

Interventions

  • CPAP Device
    Intervention Desc: CPAP at therapeutic pressure during nighttime
    ARM 1: Kind: Experimental
    Label: CPAP
    Description: CPAP at therapeutic pressure
  • CPAP at sub-therapeutic pressure Device
    Intervention Desc: CPAP delivered at sub-therapeutic pressure at nighttime
    ARM 1: Kind: Experimental
    Label: sub-therapeutic CPAP
    Description: CPAP administered at sub-therapeutic pressure

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary fatigue 10 days after beginning CPAP treatment No
Secondary quality of life 10 days after beginning CPAP treatment No
Primary Profile of Mood States (POMS) - Fatigue Subscale 10 days after beginning CPAP treatment No
Secondary Hospital Anxiety and Depression (HADS) Scale -Depression Subscale 10 days after beginning CPAP treatment No

Sponsors