Sleep Apnea Treatment After Stroke (SATS)

Terminated

Phase 2 Results

Trial Description

The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.

Detailed Description

Stroke is the leading cause of adult disability in the United States, yet there are very few treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway blockage that occurs during sleep--is common after stroke, affecting more than half of stroke patients. The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
The objective of this single-center, prospective, randomized study is to evaluate CPAP treatment in post-stroke patients. Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).
This project promises to establish feasibility, develop design and identify suitable outcome measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue, and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all stroke patients will become available.

Trial Stopped: Poor recruitment. Funding expired.

Conditions

Interventions

  • Continuous Positive airway pressure (CPAP) Device
    Intervention Desc: It is a method of respiratory ventilation used primarily in the treatment of sleep apnea, for which it was first developed.
  • Sham CPAP Device
    Intervention Desc: sham CPAP
    ARM 1: Kind: Experimental
    Label: 2
    Description: sham CPAP (placebo)
  • Continuous positive airway pressure or CPAP Device
    Intervention Desc: RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
    ARM 1: Kind: Experimental
    Label: 1
    Description: CPAP

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).

Outcomes

Type Measure Time Frame Safety Issue
Primary Hours of treatment use per week.
Secondary Functional outcome, depression, fatigue, and sleepiness.
Primary Hours of treatment use per week 3 months No
Primary Number of subjects who withdraw from study. 3 months No
Secondary Secondary outcome measures include functional outcome, depression, fatigue, and sleepiness. 3 months No
Primary Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. 3 months No
Secondary Barthel Index 3 months No

Sponsors