What is the mechanism of action of this treatment?

The SIESTA-Rehab trial focuses on two key treatments for stroke patients: nursing education and empowerment to reduce unnecessary disruptions, and a systematic protocol to screen, diagnose, and treat sleep-disordered breathing. Nursing education and empowerment aim to minimize sleep interruptions, which is crucial for neural recovery, motor learning, and overall rehabilitation outcomes. The systematic protocol for sleep-disordered breathing addresses conditions like sleep apnea, which can exacerbate stroke symptoms and hinder recovery. By improving sleep quality and addressing sleep-related issues, these treatments enhance neuroprotection and neuroplasticity, ultimately supporting better rehabilitation outcomes for stroke patients.

What side effects are associated with this type of intervention?

The SIESTA-Rehab trial focuses on nursing education and empowerment to reduce unnecessary disruptions and a systematic protocol to screen, diagnose, and treat sleep-disordered breathing. Generally, these non-pharmacologic interventions have minimal side effects. Nursing education and empowerment may lead to improved patient care and reduced stress for both patients and staff, with no significant adverse effects. Addressing sleep-disordered breathing, such as through the use of CPAP (Continuous Positive Airway Pressure) machines, can improve sleep quality and reduce stroke-related complications, though some patients may experience discomfort, nasal congestion, or claustrophobia when using CPAP devices.

What prior FDA approvals exist?

FDA-approved treatments for stroke primarily focus on acute management and secondary prevention. Intravenous tissue plasminogen activator (tPA) is a well-known FDA-approved treatment for acute ischemic stroke, aimed at dissolving blood clots. Additionally, mechanical thrombectomy devices, such as stent retrievers, are approved for removing clots in certain patients. For secondary prevention, antiplatelet agents like aspirin and clopidogrel, as well as anticoagulants such as warfarin, are commonly used. While the SIESTA-Rehab trial emphasizes non-pharmacologic interventions like nursing education and sleep-disordered breathing management, these approaches are not specifically covered by FDA drug approvals but are crucial for comprehensive stroke care.

What other types of research exist?

Promising alternatives to SIESTA-Rehab for stroke patients include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which addresses underlying insomnia and can be delivered face-to-face or online; 2) Light therapy, particularly morning light exposure, to correct circadian rhythm disturbances; 3) Lifestyle interventions focusing on diet, physical activity, and sleep hygiene education; 4) Use of wearable technologies to monitor and improve sleep patterns. These approaches can be integrated into patient care to enhance sleep and rehabilitation outcomes.

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SIESTA Rehab Education for Stroke Recovery

N/A

Waitlist Available

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Be older than 18 years old

Must not have

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

Skin allergies or irritation; open wounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help stroke patients recover better by improving their sleep during rehabilitation. It involves training nurses to avoid waking patients unnecessarily and checking for and treating any sleep-related breathing issues. Better sleep can lead to better brain recovery and learning.

Who is the study for?

This trial is for adults over 18 who've had a stroke and are admitted to the Shirley Ryan AbilityLab. They must be able to consent, follow study procedures, and have medical clearance. It's not for those with serious heart conditions, neurological diseases like MS or Alzheimer's, pregnant/nursing women, people with skin allergies/open wounds, or users of certain cardiac devices.

What is being tested?

The SIESTA program aims to improve sleep during acute stroke rehabilitation by educating nurses on minimizing disruptions and using a protocol called ApneaLink to screen and treat sleep-disordered breathing if it occurs.

What are the potential side effects?

Since this trial focuses on education and screening protocols rather than medications or invasive treatments, side effects may be minimal but could include discomfort from wearing the ApneaLink device for sleep monitoring.

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.

Exclusion Criteria

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

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

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I have skin allergies, irritations, or open wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in total sleep time as measured by Actigraphy

Karolinska Sleep Diary

Modified Potential Disruptions of Hospital Sleep Questionnaire (PDHSQ)

+1 more

Secondary study objectives

10-Meter Walk Test (10MWT)

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

Apnea Hypopnea Index (AHI)

+13 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 RehabExperimental Treatment2 Interventions

Stroke floor on which nurses will be receiving training (SIESTA Rehab Education) on how to minimize nighttime disruptions and batching overnight tasks to preserve sleep for patients hospitalized on that floor. Stroke patients admitted to the SIESTA Rehab Unit will be screening for sleep disordered breathing using ApneaLink. Patients hospitalized on this unit will be approached for consent to wear sensors and actigraphy watches during the hospital stay and after discharge.

Group II: Control UnitActive Control1 Intervention

Patients on this unit will receive usual care for stroke patients as outlined by SRALab. including routine nursing care without any intervention to promote sleep like SIESTA and routing sleep disorders screenings based on clinician judgement. Patients hospitalized on this unit will also be approached for consent to wear sensors and actigraphy watches during the hospital stay and after discharge.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The SIESTA-Rehab trial focuses on two key treatments for stroke patients: nursing education and empowerment to reduce unnecessary disruptions, and a systematic protocol to screen, diagnose, and treat sleep-disordered breathing. Nursing education and empowerment aim to minimize sleep interruptions, which is crucial for neural recovery, motor learning, and overall rehabilitation outcomes. The systematic protocol for sleep-disordered breathing addresses conditions like sleep apnea, which can exacerbate stroke symptoms and hinder recovery. By improving sleep quality and addressing sleep-related issues, these treatments enhance neuroprotection and neuroplasticity, ultimately supporting better rehabilitation outcomes for stroke patients.