Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Phase 4

Terminated

• Conditions: Stroke; Obstructive Sleep Apnea
• Interventions: Device: CPAP; Device: CPAP at sub-therapeutic pressure

• Registration Number: NCT00952211
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2016-01-27
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Results First Posted: 2016-04-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• stroke survivor in stroke rehabilitation unit
• age 45-85
• able to consent
• no prior treatment with CPAP

Exclusion Criteria

• complex apnea
• known inflammatory disease
• neurological disease precluding patient's ability to consent and cooperate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP	CPAP at therapeutic pressure
sub-therapeutic CPAP	CPAP at sub-therapeutic pressure	CPAP administered at sub-therapeutic pressure

Primary Outcome Measures

Name	Time	Method
Profile of Mood States (POMS) - Fatigue Subscale	10 days after beginning CPAP treatment	POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale	10 days after beginning CPAP treatment	HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms

Trial Locations

Locations (1)

UCSD; 🇺🇸 San Diego, California, United States