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Sleep-Promoting Interventions for Stroke Rehabilitation (SIESTA-Rehab Trial)
N/A
Recruiting
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout 3 months of follow-up
Awards & highlights
SIESTA-Rehab Trial Summary
This trial is testing whether two sleep-promoting interventions can help improve sleep and rehabilitation outcomes for stroke patients in the hospital.
Who is the study for?
This trial is for adults who've had a stroke and are in the Shirley Ryan AbilityLab. They must be able to consent to the study and follow its procedures. It's not for those who are pregnant, nursing, have skin issues or open wounds, use certain heart devices like pacemakers, or have serious heart conditions or degenerative neurological diseases.Check my eligibility
What is being tested?
The SIESTA-Rehab Protocol is being tested to see if it improves sleep and rehabilitation outcomes after a stroke. It involves empowering nurses to minimize disruptions and systematically screening, diagnosing, and treating sleep-disordered breathing compared with standard care.See study design
What are the potential side effects?
Since this trial focuses on non-invasive interventions aimed at improving sleep patterns rather than medication or surgery, specific side effects aren't detailed but may include discomfort from wearing sleep monitoring equipment.
SIESTA-Rehab Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am 18 years old or older.
SIESTA-Rehab Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout 3 months of follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout 3 months of follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality Indicator (QI) score
Secondary outcome measures
10-Meter Walk Test (10MWT)
6-Minute Walk Test with VO2 analysis (6MWT)
Actigraphy Measures of Sleep Quality
+14 moreSIESTA-Rehab Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SIESTA-Rehab ProtocolExperimental Treatment1 Intervention
This inpatient rehabilitation floor will be trained to implement the SIESTA-Rehab protocol. Nurses will be empowered to reduce unnecessary disruptions and subjects will be screened for sleep-disordered breathing. Subjects will utilize wearable sensor technology.
Group II: Standard of CareActive Control1 Intervention
This inpatient rehabilitation floor will continue to implement usual care.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have skin allergies, irritations, or open wounds.You have been diagnosed with a stroke and are staying at the Shirley Ryan AbilityLab as an inpatient.I do not have serious heart conditions or degenerative brain diseases like MS, Alzheimer's, or Parkinson's.You have a powered implanted device in your heart to help monitor or support its function, like a pacemaker or defibrillator.I am 18 years old or older.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: SIESTA-Rehab Protocol
- Group 2: Standard of 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 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.
Are participants being actively enrolled in this investigation?
"Affirmative. Clinicaltrials.gov reveals that the study, first posted on July 20th 2020, is still seeking participants. This research endeavour necessitates 400 volunteers from a single location to be enrolled in it."
Answered by AI
What is the sample size of this investigation?
"Affirmative. Clinicaltrials.gov reflects that this medical trial, which was initially announced on July 20th 2020, is actively gathering participants. In total 400 patients will be enrolled at one site of the study."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
65+
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria
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