Sleep Apnea Treatment After Stroke (SATS)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Treatment of Obstructive Sleep Apnea After Stroke

Conditions
-----------------
Obstructive Sleep Apnea, Stroke

Intervention / Treatment
-----------------
* Device: continuous positive airway pressure or CPAP
* Device: sham CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke within 7 days of planned polysomnography/sleep screening study Modified Rankin Scale score >1 If of child-bearing potential, has a negative urine or serum pregnancy test Exclusion Criteria: Decompensated heart failure Cardiac or respiratory arrest within the past 3 months Myocardial infarction within the past 3 months Severe pneumonia Hypertension refractory to treatment Any other unstable medical condition which is thought to interfere with participation Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP Previous pneumothorax Bullous emphysema Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP Acute sinus or ear infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>CPAP | Device: continuous positive airway pressure or CPAP<br>* 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.<br>|
| Sham Comparator: 2<br>sham CPAP (placebo) | Device: sham CPAP<br>* sham CPAP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period. |  | 3 months | 
| Number of Subjects Who Withdraw From Study. | Prespecified outcome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent). | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, stroke, OSA, CPAP, continuous positive airway pressure