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Positive Airway Pressure Therapy
Positive Airway Pressure for Stroke Recovery (RISE-UP Trial)
N/A
Recruiting
Led By Klar Yaggi, MD, MPH
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate (15 =< overall AHI < 30) /severe (overall AHI >= 30) OSA, thus with an obstructive apnea-hypopnea index AHI >= 15
Being within 5 days of neurologic symptoms onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights
RISE-UP Trial Summary
This trial will compare the effects of PAP treatment versus usual care for people with acute ischemic stroke and moderate to severe OSA. The primary outcome is functional recovery.
Who is the study for?
This trial is for adults who've had an acute ischemic stroke within the past 5 days and have moderate to severe obstructive sleep apnea (OSA), confirmed by a sleep study. Participants must be able to give informed consent and not require mechanical ventilation, have other sleep disorders, or a life expectancy under 6 months.Check my eligibility
What is being tested?
The study is testing if Positive Airway Pressure (PAP) treatment improves recovery after an acute ischemic stroke compared to usual care. It's a randomized controlled trial with around 180 participants diagnosed with OSA using ambulatory polysomnography.See study design
What are the potential side effects?
While specific side effects are not listed, PAP therapy can sometimes cause discomfort, nasal congestion, dry mouth, skin irritation from the mask, and rarely lung discomfort.
RISE-UP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe sleep apnea with an AHI of 15 or higher.
Select...
My neurological symptoms started less than 5 days ago.
RISE-UP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Katz Scale
Modified Rankin Scale (mRS)
Secondary outcome measures
Change in Berg Balance Scale
Change in Insomnia Severity Index (ISI) Severity Index
Change in PROMIS Pain Intensity - Short Form 3a V1.0
+13 moreOther outcome measures
Circadian Rhythms
Polysomnographic measures of sleep apnea severity
Positive airway pressure adherence
RISE-UP Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: PAP treatment- SubacuteExperimental Treatment2 Interventions
Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
Group II: PAP treatment- AcuteExperimental Treatment2 Interventions
Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
Group III: Exploratory armExperimental Treatment1 Intervention
Non-randomized comparison/exploratory group of subjects with ischemic stroke and Apnea-Hypopnea Index (AHI) <15 (approximately 120 participants) and approximately 60 subjects with ICH (who do not need legally authorized representative for consent - most likely mild form of ICH) and any level of AHI.
Group IV: Usual Care (HLE)Active Control1 Intervention
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PAP
2016
N/A
~90
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,081 Total Patients Enrolled
9 Trials studying Ischemic Stroke
2,322 Patients Enrolled for Ischemic Stroke
Hartford HealthCareOTHER
8 Previous Clinical Trials
924 Total Patients Enrolled
Klar Yaggi, MD, MPHPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe sleep apnea with an AHI of 15 or higher.You are expected to live for less than 6 months, such as if you are receiving hospice care.I do not require mechanical ventilation to breathe.My neurological symptoms started less than 5 days ago.If you've had a recent stroke, and your brain was scanned within 48 hours of when the symptoms started.More than half of my breathing issues during sleep are due to central sleep apnea.Your oxygen level while resting is less than 90%.I might have a sleep disorder that is not obstructive sleep apnea.You have used a prescribed PAP machine for sleep apnea in the past.You must be able to speak English because the study involves building a connection between you and the research team.
Research Study Groups:
This trial has the following groups:- Group 1: Exploratory arm
- Group 2: PAP treatment- Subacute
- Group 3: Usual Care (HLE)
- Group 4: PAP treatment- Acute
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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been enrolled in this clinical experiment?
"Indeed, the trial posted on September 1st 2019 is presently recruiting participants according to clinicaltrials.gov. The last update was made December 6th 2021 and this trial seeks 180 patients from a single location."
Answered by AI
Are there any open spots for participants in this research endeavor?
"Yes, according to clinicaltrials.gov, this investigation is actively enrolling patients. Initially posted on September 1st 2019 and most recently updated on December 6th 2021, the study requires 180 people from a single medical centre."
Answered by AI
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