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Positive Airway Pressure Device

CPAP for Stroke (Sleep SMART Trial)

N/A
Recruiting
Led By Ronald Chervin, 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

Sleep SMART Trial 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.

Eligible Conditions
  • Stroke
  • Telemedicine
  • Home Sleep Apnea Test
  • Multicenter Trial
  • CPAP
  • Ischemic Stroke
  • Randomized Clinical Trial
  • Sleep Apnea
  • Obstructive Sleep Apnea
  • Mini Stroke

Sleep SMART Trial Timeline

Screening ~ 14 days
Treatment ~ 6 months
Follow Up ~6 months
This trial's timeline: 14 days for screening, 6 months for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Modified Rankin Scale Score
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
Secondary outcome measures
NIH Stroke Score (NIHSS)
Quality of Life outcome
Short Montreal Cognitive Assessment (MoCA) Score

Sleep SMART 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
427 Previous Clinical Trials
631,300 Total Patients Enrolled
31 Trials studying Stroke
13,162 Patients Enrolled for Stroke
FusionHealth LLCUNKNOWN
Medical University of South CarolinaOTHER
932 Previous Clinical Trials
7,391,198 Total Patients Enrolled
67 Trials studying Stroke
56,989 Patients Enrolled for Stroke

Media Library

CPAP (Positive Airway Pressure Device) Clinical Trial Eligibility Overview. Trial Name: NCT03812653 — N/A
Stroke Research Study Groups: Intervention Arm: CPAP with Usual Care., Control Arm: Usual Care.
Stroke Clinical Trial 2023: CPAP Highlights & Side Effects. Trial Name: NCT03812653 — N/A
CPAP (Positive Airway Pressure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03812653 — N/A
Stroke Patient Testimony for trial: Trial Name: NCT03812653 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study currently recruiting participants?

"As per information accessible on clinicaltrials.gov, this medical trial is presently recruiting patients. This research project was first posted online on May 9th 2019 and has recently been updated on March 25th 2022."

Answered by AI

Are there multiple sites in the US offering this clinical trial?

"At this point in time, 100 different trial sites are enrolling patients. These locations span from Miami to Los Angeles and everywhere between; it is ideal for participants to select the closest site possible so as to reduce their travel needs."

Answered by AI

How many participants are presently taking part in this research?

"This clinical trial requires 3062 eligible patients to complete it. Sites participating in this project are located at the Baptist Hospital of Miami, Florida and Staten Island University Hospital, New york."

Answered by AI

Who else is applying?

What state do they live in?
Maine
California
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
UCLA Kaiser Fontana
Eastern Maine Medical Center
Memorial Hermann Texas Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

Treat my condition. I'm always snoring in my sleep. Been diagnosed. Never treated.
PatientReceived 2+ prior treatments
I fear I may have another TIA or Stroke. I haven't tried any specific medications but am willing to try.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Will there be any compensation?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Sleep for Stroke Management and Recovery Trial
Devin L. Brown, MD 2019. "Sleep for Stroke Management and Recovery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03812653.
~518 spots leftby Apr 2025
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