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Positive Airway Pressure Device
CPAP for Sleep Apnea After Stroke (Sleep SMART Trial)
N/A
Recruiting
Led By Devin Brown, MD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 14 days
Treatment 6 months
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether treating sleep apnea soon after a stroke or TIA reduces the risk of having another stroke, a heart attack, or death. It will also test whether treating sleep apnea improves stroke outcomes 3 months after the event.
Who is the study for?
This trial is for individuals who've had a TIA with an ABCD2 score of at least 4 or an ischemic stroke within the last two weeks. It's not suitable for those with certain physical anomalies, severe lung disease, recent major skull surgery, high oxygen needs, current infections requiring isolation, pregnant women, mechanical ventilation users (unless resolved), prior CPAP use within a month before the stroke, history of spontaneous pneumothorax or massive epistaxis.
What is being tested?
The study tests if using CPAP to treat obstructive sleep apnea soon after an ischemic stroke can reduce further strokes or heart issues and death from any cause six months later. It also checks if it helps improve recovery three months post-stroke. Participants are randomly chosen to receive either CPAP treatment or no such intervention in multiple centers.
What are the potential side effects?
CPAP may cause discomfort like skin marks or sores where the mask touches the face; dry nose/mouth; feelings of claustrophobia; sinus pressure changes leading to headaches; and potential ear discomfort due to air pressure changes.
Timeline
Screening ~ 14 days1 visit
Treatment ~ 6 months1 visit
Follow Up ~ 6 months2 visits
Screening ~ 14 days
Treatment ~ 6 months
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Modified Rankin Scale Score
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
Secondary study objectives
NIH Stroke Score (NIHSS)
Quality of Life outcome
Short Montreal Cognitive Assessment (MoCA) Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm: CPAP with Usual Care.Experimental Treatment1 Intervention
6 months of CPAP plus usual medical therapy.
Group II: Control Arm: Usual Care.Active Control1 Intervention
6 months of usual medical therapy alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPAP
2013
Completed Phase 3
~5460
Find a Location
Who is running the clinical trial?
University of CincinnatiOTHER
439 Previous Clinical Trials
635,686 Total Patients Enrolled
FusionHealth LLCUNKNOWN
Medical University of South CarolinaOTHER
977 Previous Clinical Trials
7,397,855 Total Patients Enrolled
University of MichiganLead Sponsor
1,861 Previous Clinical Trials
6,437,962 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,382 Previous Clinical Trials
649,289 Total Patients Enrolled
Devin Brown, MD, MSPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
342 Total Patients Enrolled
Ronald Chervin, MD, MSPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a physical abnormality or skin condition that makes it impossible to use the CPAP device.You have a serious lung condition called bullous lung disease.You have a history of lung collapse without any external cause, or you currently have a lung collapse.You have a history of severe nosebleeds.You are currently receiving medication to treat low blood pressure (hypotension). If this resolves, you may be able to enroll in the study later.You have other medical conditions that make it dangerous for you to use a CPAP machine, as determined by the doctor in charge of the study site.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm: CPAP with Usual Care.
- Group 2: Control Arm: Usual Care.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 14 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multicenter Trial Patient Testimony for trial: Trial Name: NCT03812653 — N/A