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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ApneaLink, SIESTA Rehab Education for stroke recovery?

Research suggests that good sleep quality and duration are important for recovery after a stroke, as they are linked to better functional abilities and rehabilitation outcomes. Although the studies do not directly evaluate ApneaLink or SIESTA Rehab Education, they highlight the importance of addressing sleep issues in stroke recovery, which these treatments may help improve. ^{1 2 3 4 5}

Is the SIESTA Rehab Education for Stroke Recovery safe for humans?

The research articles do not provide specific safety data for SIESTA Rehab Education or related treatments like ApneaLink. They focus on sleep disturbances and their impact on stroke recovery, but do not address safety concerns directly. ^{5 6 7 8 9}

How is the SIESTA Rehab Education treatment different from other stroke recovery treatments?

SIESTA Rehab Education is unique because it emphasizes the role of sleep in stroke recovery, focusing on improving sleep quality and quantity to enhance neuroplasticity (the brain's ability to reorganize itself) and functional recovery. Unlike traditional rehabilitation, this approach integrates sleep management as a core component of the recovery process. ^{3 5 7 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Post-stroke sleep disturbances and rehabilitation outcomes: a prospective cohort study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sleep Quantity and Quality During Inpatient Rehabilitation After Stroke. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Association Between Sleep Duration and Functional Disability in Inpatient Stroke Rehabilitation: A Pilot Observational Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Sleep aids recovery from stroke. [2019]

6. Switzerland 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Study Protocol: Sleep Effects on Poststroke Rehabilitation Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep and Stroke: New Updates on Epidemiology, Pathophysiology, Assessment, and Treatment. [2023]

9. England pubmed.ncbi.nlm.nih.gov

EAN/ERS/ESO/ESRS statement on the impact of sleep disorders on risk and outcome of stroke. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The role of sleep in recovery following ischemic stroke: A review of human and animal data. [2020]