Sleep for Stroke Management and Recovery Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Detailed Description
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Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Official Title
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Sleep for Stroke Management and Recovery Trial

Conditions
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Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, TIA, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days. Exclusion Criteria: pre-event inability to perform all of own basic ADLs unable to obtain informed consent from subject or legally authorized representative incarcerated known pregnancy current mechanical ventilation (can enroll later if this resolves) or tracheostomy current use of positive airway pressure, or use within one month prior to stroke anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible severe bullous lung disease history of prior spontaneous pneumothorax or current pneumothorax hypotension requiring current treatment with pressors (can enroll later if this resolves) other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP massive epistaxis or previous history of massive epistaxis cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure current receipt of oxygen supplementation >4 liters per minute current contact, droplet, respiratory/airborne precautions

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm: CPAP with Usual Care.<br>6 months of CPAP plus usual medical therapy. | Device: CPAP<br>* Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.<br>|
| No Intervention: Control Arm: Usual Care.<br>6 months of usual medical therapy alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality | The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality | 6 months post randomization | 
| Modified Rankin Scale Score | Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death). | 3 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Stroke Score (NIHSS) | Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42. | 3 months post randomization | 
| Short Montreal Cognitive Assessment (MoCA) Score | Cognitive outcome is measured by the Short MoCA. The short MoCA is a 5 minute short version of the Montreal Cognitive Assessment (MoCA). This instrument tests phonemic verbal fluency (1 point), delayed recall (5 points), and orientation (6 points) with a score ranging from 0-12. | 3 months post randomization | 
| Quality of Life outcome | Quality of life outcome is measured by the shortened Stroke Specific Quality of Life Scale (SS-QOL). The short SS-QOL has 7 domains that include physical function, language, vision, thinking, energy, mood, and role function. There is 1 question from each domain. The 12 item SS-QOL is calculated by averaging the scores of these 12 questions. | 3 months post randomization |