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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

Must not have

Skin allergies or irritation; open wounds

Serious cardiac conditions or neurological degenerative pathologies as comorbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout 3 months of follow-up

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have skin allergies, irritations, or open wounds.

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I do not have serious heart conditions or degenerative brain diseases like MS, Alzheimer's, or Parkinson's.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout 3 months of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality Indicator (QI) score

Secondary study objectives

10-Meter Walk Test (10MWT)

6-Minute Walk Test with VO2 analysis (6MWT)

Actigraphy Measures of Sleep Quality

+14 more

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: 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.

0 / 4Eligibility criteria met