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CPAP Treatment for Stroke (SCOUTS3 Trial)

N/A
Recruiting
Led By Sandeep Khot, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment
Awards & highlights

SCOUTS3 Trial Summary

This trial is studying how best to treat breathing problems during sleep (OSA) in stroke survivors to improve stroke outcomes.

Who is the study for?
This trial is for adults who've had a recent stroke, confirmed by CT or MRI within the last 30 days. They must be able to give consent in English or Spanish. It's not for those with strokes from tumors, certain lung conditions, using sedatives that affect sleep tests, on mechanical breathing support, pregnant women, or anyone unable to use CPAP.Check my eligibility
What is being tested?
SCOUTS3 aims to improve outcomes after stroke by increasing the effectiveness of CPAP therapy during intensive rehabilitation for obstructive sleep apnea (OSA). The study includes motivational enhancement and mobile health interventions alongside technical support for CPAP users.See study design
What are the potential side effects?
CPAP may cause discomfort like dry nose/mouth, nasal congestion, sore throat; MET and mobile health interventions are generally low-risk but could include minor psychological distress.

SCOUTS3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I had a stroke or brain bleed shown on a scan in the last 30 days.

SCOUTS3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at follow-up timepoint of 90 +/- 14 days after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at follow-up timepoint of 90 +/- 14 days after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CPAP Adherence
Secondary outcome measures
Functional Disability
Stroke Severity
Other outcome measures
CPAP partner burden

SCOUTS3 Trial Design

1Treatment groups
Experimental Treatment
Group I: SCOUTS3 Optimization ArmExperimental Treatment4 Interventions
In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous positive airway pressure (CPAP)
2006
Completed Phase 4
~1650
Motivational Enhancement Therapy (MET)
2008
Completed Phase 3
~1510

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,706 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,064 Total Patients Enrolled
Sandeep Khot, MD, MPHPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

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

Are there any remaining openings for participants to become involved in this clinical trial?

"According to clinicaltrials.gov, this medical study does not currently have any immediate openings for participants. It was initially published on September 18th 2023 and had its last update a few weeks later on the 1st of the same month. Nevertheless, there are presently over 1800 other studies that actively require volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Stroke and CPAP Outcome Study 3
Sandeep Khot 2023. "Stroke and CPAP Outcome Study 3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029959.
~13 spots leftby Jun 2024
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