SIESTA Rehab Education for Stroke Recovery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Serious cardiac, Neurological degenerative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 17 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve stroke recovery by enhancing sleep during rehabilitation. Researchers are testing a program called SIESTA Rehab Education, which trains nurses to minimize nighttime disruptions and screen patients for sleep disorders. The trial includes two groups: one receiving the sleep-focused treatment and a control group receiving regular care. Stroke patients staying at the Shirley Ryan AbilityLab may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke recovery through better sleep.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for stroke patients?

Research shows that the SIESTA Rehab Education program aims to improve sleep for stroke patients. It achieves this by training nurses to avoid unnecessary nighttime disturbances and by screening patients for sleep-related breathing issues. Studies on SIESTA report no safety issues or negative effects from these sleep methods. Instead, they highlight positive feedback from staff, indicating that the program is well-received and effective in hospitals.

The trial is labeled as "Not Applicable" for a phase, likely indicating the use of behavioral methods, such as sleep education, rather than medications or surgeries. These methods are generally considered low-risk. However, without specific safety data, concrete evidence about safety concerns cannot be provided. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIESTA Rehab Education because it focuses on minimizing nighttime disruptions for stroke patients, which is a novel approach compared to standard care that doesn't emphasize sleep preservation. Unlike typical stroke recovery treatments, which often center on medication and physical rehabilitation, SIESTA aims to optimize the healing environment by training nurses to batch tasks and screen for sleep disorders like sleep apnea. By prioritizing quality sleep, this method could enhance recovery, potentially leading to improved outcomes for stroke patients.

What evidence suggests that the SIESTA Rehab Education and ApneaLink interventions could be effective for stroke recovery?

Research shows that stroke patients often struggle with sleep during recovery, which can hinder their progress. This trial tests the SIESTA-Rehab Education program as an intervention by training nurses to reduce nighttime disturbances and address sleep-related breathing issues. Studies have found that better sleep can enhance recovery for stroke patients. By focusing on improved sleep, the SIESTA-Rehab program aims to support recovery by aiding brain healing, enhancing movement skills, and protecting the brain. Early results suggest that this approach could improve both sleep and recovery for stroke patients. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Medical clearance from physician

You are currently staying at the Shirley Ryan AbilityLab due to a stroke.

Able and willing to give written consent and comply with study procedures

Exclusion Criteria

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

You have a powered heart monitoring or support device implanted, like a pacemaker or defibrillator.

I have skin allergies, irritations, or open wounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive sleep-promoting interventions including nursing education and screening for sleep-disordered breathing during acute stroke rehabilitation

17 days

Daily monitoring during inpatient stay

Follow-up

Participants are monitored for sleep quality and rehabilitation outcomes post-discharge

3 months

1-month, 2-month, and 3-month post-discharge follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• ApneaLink
• SIESTA Rehab Education

Trial Overview 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.

How Is the Trial Designed?

Group I: SIESTA Rehab Experimental Treatment 2 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 Unit Active Control 1 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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study of 69 stroke patients undergoing inpatient rehabilitation, all participants exhibited poor sleep quantity and quality, with none meeting recommended sleep guidelines.

Participants with sleep efficiency below 85% experienced a significantly longer length of stay in rehabilitation (21.5 days) compared to those with better sleep efficiency (17.4 days), indicating that poor sleep may hinder recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Quantity and Quality During Inpatient Rehabilitation After Stroke. Fulk, G., Billinger, S., Bartsch, B., et al.[2023]

A study involving 18 adults with stroke found that a low-cost sleep monitoring device (Withings Sleep Analyzer) showed poor agreement with a standard device (Philips Actiwatch) in measuring sleep parameters, indicating potential inaccuracies.

The findings suggest that while low-cost devices may not be suitable for monitoring sleep quality in hospital settings, further research with larger groups is necessary to explore their utility and accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Sleep Quality in the Hospital Environment with Wearable and Non-Wearable Devices in Adults with Stroke Undergoing Inpatient Rehabilitation. Pellegrini, M., Lannin, NA., Mychasiuk, R., et al.[2023]

In a study of 37 individuals recovering from acute stroke, most participants experienced less than optimal sleep duration during their inpatient rehabilitation, with 57% categorized as 'poor sleepers'.

Despite the hypothesis that better sleep quality would lead to greater functional ability at discharge, sleep outcomes did not significantly predict functional disability scores, suggesting that improving sleep alone may not enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Sleep Duration and Functional Disability in Inpatient Stroke Rehabilitation: A Pilot Observational Study. Williams-Cooke, C., Watts, E., Bonnett, J., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-stroke-6-2020-4fe2f

SIESTA Rehab Education for Stroke Recovery In a study of 69 stroke patients undergoing inpatient rehabilitation, all participants exhibited poor sleep quantity and quality, with none meeting recommended ...

2. sralab.org sralab.org/research/labs/max-nader-rto/projects/improving-sleep-inpatients

Empower Staff to Act for Acute Stroke Rehabilitation (SIESTA) We will study the effectiveness of SIESTA-Rehab on improving sleep and rehabilitation outcomes during acute rehabilitation for stroke and after discharge home.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04536623/siesta-for-acute-stroke-rehabilitation

SIESTA for Acute Stroke Rehabilitation This study aims to determine the effectiveness of the SIESTA-Rehab protocol compared to usual care on inpatient sleep and stroke rehabilitation ...

4. withpower.com withpower.com/trial/phase-stroke-6-2020-118c3

Sleep-Promoting Interventions for Stroke Rehabilitation Trial Overview The SIESTA-Rehab Protocol is being tested to see if it improves sleep and rehabilitation outcomes after a stroke. It involves empowering nurses ...

5. reporter.nih.gov reporter.nih.gov/project-details/10813916

braun, robynne - NIH RePORTER The proposed research is innovative in pairing longitudinal transcriptomics with domain-specific measures of stroke recovery and quantitative measures of ...

6. academic.oup.com academic.oup.com/sleep/article/47/Supplement_1/A470/7655206

Empowering Staff to Act) Protocol for Acute Stroke Rehabilitation The SIESTA protocol can be successfully adapted to an acute rehabilitation setting for stroke patients, as evidenced by positive staff responses.

7. ovid.com ovid.com/journals/clrb/fulltext/10.1177/02692155251375369~adapting-and-implementing-a-staff-led-sleep-intervention-in

Adapting and implementing a staff-led sleep... SIESTA-Rehab can be successfully implemented in an acute rehabilitation setting, as indicated through positive staff responses. Introduction. Sleep plays a ...

8. researchgate.net researchgate.net/publication/379984427_1095_Adaptation_of_SIESTA_Sleep_for_Inpatients_Empowering_Staff_to_Act_Protocol_for_Acute_Stroke_Rehabilitation

1095 Adaptation of SIESTA (Sleep for Inpatients ... SIESTA-Rehab. The protocol included educational video modules for nurses regarding sleep hygiene and sleep apnea screening, sleep enhancing ...