Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Conditions
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Stroke, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP
* Device: CPAP at sub-therapeutic pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP<br>CPAP at therapeutic pressure | Device: CPAP<br>* CPAP at therapeutic pressure during nighttime<br>|
| Sham Comparator: sub-therapeutic CPAP<br>CPAP administered at sub-therapeutic pressure | Device: CPAP at sub-therapeutic pressure<br>* CPAP delivered at sub-therapeutic pressure at nighttime<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, obstructive sleep apnea, fatigue, quality of life