Sleep-Promoting Interventions for Stroke Rehabilitation

(SIESTA-Rehab Trial)

Overseen By Sara Prokup, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Serious cardiac, Neurological degenerative, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help stroke patients recover by improving their sleep in the hospital. It combines two methods: reducing unnecessary disruptions during sleep and checking for sleep breathing issues, such as sleep apnea. Participants will be split into two groups: one following this new sleep-focused approach, called the SIESTA-Rehab Protocol, and the other receiving standard care. The trial seeks stroke patients currently in the hospital who have been medically cleared by their doctor and are willing to participate.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery for future stroke patients.

Will I have to stop taking my current medications?

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 the SIESTA-Rehab Protocol is safe for stroke rehabilitation?

Research has shown that the SIESTA-Rehab Protocol has been successfully used with stroke patients in a rehabilitation setting. Staff feedback has been positive, indicating that the protocol is well-received. Studies have focused on improving sleep for stroke patients, which is crucial for their recovery.

Although specific safety data is not mentioned, the protocol involves training nurses to minimize disruptions and check for sleep disorders, suggesting it is non-invasive. This approach appears promising in aiding recovery without introducing new risks. Its "Not Applicable" phase indicates the protocol is considered safe for practical use rather than testing a new drug or device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIESTA-Rehab Protocol because it offers a fresh approach to enhancing recovery for stroke patients by focusing on improving sleep. Unlike the standard care, which typically doesn't prioritize sleep management, this protocol empowers nurses to minimize unnecessary nighttime disruptions and actively screens patients for sleep-disordered breathing. Plus, by incorporating wearable sensor technology, the protocol allows for precise monitoring of sleep patterns, which could lead to more personalized and effective rehabilitation strategies.

What evidence suggests that the SIESTA-Rehab Protocol is effective for stroke rehabilitation?

Research has shown that the SIESTA-Rehab Protocol, which participants in this trial may receive, can aid stroke recovery. Studies have found that improving sleep and addressing sleep problems can enhance recovery. For instance, when nurses reduce unnecessary disturbances, patients often sleep better. Good sleep supports brain function and healing, both crucial for stroke recovery. Additionally, treating sleep-related breathing issues, such as sleep apnea, can improve rehabilitation outcomes. These combined efforts aim to enhance the rehabilitation process for stroke patients. ^{3 4 5 6 7}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Medical clearance from physician

You have been diagnosed with a stroke and are staying at the Shirley Ryan AbilityLab as an inpatient.

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

Exclusion Criteria

I have skin allergies, irritations, or open wounds.

Pregnant or nursing

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Upon admission

Inpatient Treatment

Implementation of the SIESTA-Rehab protocol, including nurse education to reduce disruptions and screening for sleep-disordered breathing

17 days

Continuous inpatient stay

Follow-up

Participants are monitored for sleep, physical activity, and functional performance at home

3 months

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

What Are the Treatments Tested in This Trial?

Interventions

• SIESTA-Rehab Protocol

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 to minimize disruptions and systematically screening, diagnosing, and treating sleep-disordered breathing compared with standard care.

How Is the Trial Designed?

Group I: SIESTA-Rehab Protocol Experimental Treatment 1 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 Care Active Control 1 Intervention

This inpatient rehabilitation floor will continue to implement usual care.

SIESTA-Rehab Protocol is already approved in United States for the following indications:

Approved in United States as SIESTA-Rehabilitation Protocol for:

• Acute Stroke Rehabilitation
• Sleep-Disordered Breathing

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

A sleep hygiene intervention (SHP) was implemented for 22 individuals with traumatic brain injury (TBI) in a rehabilitation unit, which included blue-light therapy and restrictions on caffeine and napping.

The SHP led to significant improvements in sleep metrics compared to standard care, indicating that nonpharmacologic approaches can effectively address sleep disruption in TBI patients, warranting further research on its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized Sleep After Brain Injury (OSABI): A Pilot Study of a Sleep Hygiene Intervention for Individuals With Moderate to Severe Traumatic Brain Injury. Makley, MJ., Gerber, D., Newman, JK., et al.[2021]

In a pilot study involving 51 participants, a sleep clinical pathway did not show significant improvements in sleep quality compared to standard care, as measured by various scales including the Pittsburgh Sleep Quality Index.

Despite no differences between the intervention and control groups, the overall cohort experienced significant improvements in sleep quality, fatigue, therapy engagement, and satisfaction with sleep from admission to discharge, indicating that rehabilitation may naturally enhance these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Novel Sleep Clinical Pathway in an Inpatient Musculoskeletal Rehabilitation Cohort: A Pilot Randomized Controlled Trial. Hsu, J., Kee, K., Perkins, A., et al.[2022]

The sleep enhancement protocol (SEP) significantly reduced nighttime room entries (NREs) by approximately 50% for patients with orthopedic injuries (OI), indicating improved sleep efficiency and reduced daytime fatigue.

However, the SEP did not show a significant effect on NREs for patients with acquired brain injuries (ABI), suggesting that tailored approaches may be needed for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Sleep Enhancement Protocol on Nighttime Room Entries in an Inpatient Rehabilitation Facility. Sullan, MJ., Patel, BB., Bauer, RM., et al.[2021]

Continuous positive airway pressure (CPAP) is the only nonpharmacological intervention shown to improve physical rehabilitation outcomes in individuals with stroke and sleep apnea, based on a systematic review of 9 randomized controlled trials.

Participants who adhered well to CPAP therapy experienced the most significant improvements in their rehabilitation, highlighting the importance of compliance for maximizing treatment benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review Investigating the Effects of Nonpharmacological Interventions During Sleep to Enhance Physical Rehabilitation Outcomes in People With Neurological Diagnoses. Johnson, BP., Shipper, AG., Westlake, KP.[2019]

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]

Patients in an acute inpatient rehabilitation unit reported significantly better sleep quality across various domains compared to their experiences in the acute care hospital, indicating that rehabilitation settings may enhance sleep quality.

While sleep quality in the rehabilitation unit was comparable to home, patients noted increased noise levels during their stay, suggesting that while rehabilitation improves sleep, environmental factors still play a role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Sleep Quality in Acute Inpatient Rehabilitation. Davis, SM., Mekany, M., Kim, JJ., et al.[2022]

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]

Over half of the adult patients (58.2%) admitted for brain injury rehabilitation experienced sleep disturbances, with increased sleep onset latency being the most common issue (28.5%).

Obstructive sleep apnea (OSA) was linked to longer hospital stays and reduced cognitive rehabilitation efficiency, highlighting the need for routine screening for sleep issues in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbance and length of stay in the setting of acquired brain injury rehabilitation. Dey, A., Kam, A., Tam, A., et al.[2021]

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. reporter.nih.gov reporter.nih.gov/search/_KHTVkv4XUGS-OL7AjfdOg/project-details/9903969

RePORT RePORTER - National Institutes of Health (NIH) | SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation - Resubmission 01. Project Number1R01HD097786-01A1. Contact PI/Project ...

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. clinicaltrial.be clinicaltrial.be/en/details/177007?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

SIESTA (Sleep of Inpatients: Empower Staff to Act) for Ac... This subjective questionnaire asks inpatients how specific items disrupted their sleep the prior night from 1 (not disruptive) to 5 (extremely disruptive).

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

SIESTA for Acute Stroke Rehabilitation The SIESTA-Rehab protocol consists of two parts. First, nurses will be educated and empowered to reduce unnecessary disruptions. This will begin ...

5. 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 ...

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. 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 Introduction Improving sleep for patients with stroke is vital due to the importance of sleep for neuroplasticity and functional recovery.