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SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254484
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Shirley Ryan AbilityLab
Northwestern University
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
Given the critical role of sleep in enhancing neural recovery, motor learning, neuroprotection, and neuroplasticity, interventions to enhance sleep that target sleep could improve recovery and rehabilitation outcomes for stroke patients. In this proposal, a multidisciplinary group of researchers with expertise in rehabilitation medicine, sleep medicine, nursing, physical therapy, wearable technologies, and implementation science will adapt, implement and evaluate a state-of-the-art intervention to promote sleep for stroke patients undergoing acute rehabilitation. SIESTA-Rehab, adapted from a previous unit-based intervention, bundles two sleep-promoting interventions to address the unique sleep challenges stroke patients face during acute rehabilitation: (1) nursing education and empowerment to reduce unnecessary disruptions; (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing if present during acute stroke rehabilitation.

Condition or disease Intervention/treatment Phase
Sleep Sleep Disordered Breathing Stroke Behavioral: SIESTA Rehab Education Diagnostic Test: ApneaLink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SIESTA Rehab

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.

Behavioral: SIESTA Rehab Education
Staff nurses will be trained on how to improve sleep in stroke patients in the acute rehabilitation setting.

Diagnostic Test: ApneaLink
Stroke patients on the SIESTA Rehab unit will be screened for sleep disordered breathing using ApneaLink monitors. Results will be interpreted by a sleep specialist who will then advise the clinical team at SRALab.

No Intervention: Control Unit

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.




Primary Outcome Measures :
  1. Change in Sleep Duration [ Time Frame: Up to 6 months ]
    Actiwatches are small, rugged, actigraphy-based data loggers that record a digitally integrated measure of gross motor activity using a highly sensitive accelerometer. With each subject movement an accelerometer generates a variable voltage that is digitally processed and sampled at a frequency of 32 Hz. The signal is integrated over a user-selected epoch and a value expressed as "Activity Counts" is recorded in onboard memory. Data may be expressed graphically as actograms. The Philips Actiwatch can record up to 60 days using 30-second epochs or until data is downloaded. Actigraphy data is analyzed using associated software (Actiware v5) which uses algorithms to determine sleep duration, sleep efficiency and wake after sleep onset (WASO).The Actiwatch will be worn on the non-dominant wrist, unless that arm has limited mobility, in which case the other wrist will be used.

  2. Change in Functional Independence Measure (FIM) Score [ Time Frame: Up to 6 months ]
    The FIM is an 18-item test (13 motor tasks, 5 cognitive tasks) for evaluating level of disability, and how much assistance is needed for a subject to perform certain activities of daily living. Each item is scored on a 7-point ordinal scale, ranging from total assistance (1) to total independence (7). Items include eating, grooming, bathing, dressing, toileting, bladder/bowel management, transfers, locomotion and stairs, comprehension, etc. The minimally clinical important difference for people with acute stroke is 22 points (17 on motor subscale, 3 on cognitive subscale). The FIM has been shown to be a valid predictor of outcome after discharge from rehabilitation in stroke patients.


Secondary Outcome Measures :
  1. Apnea Hypopnea Index (AHI) [ Time Frame: 8 hours ]
    obtained from the ApneaLink™ devices, which are simple, cost-effective portable devices for diagnosing sleep-disordered breathing. It automatically analyzes and derives an AHI, flow limitation, snoring and oxygen desaturation index. The automatic analysis will be reviewed by an expert sleep specialist to ensure correct interpretation. The AHI is calculated based on number of events of apnea or blood O2 desaturation per hour, with <5 being normal and >30 being severe

  2. Activity counts [ Time Frame: Up to 6 months ]
    As captured by actigraph GT9X worn around the waist. The specific parameters used to monitor mobility and clinical performance are step count, intensity, dose of rehabilitation, and activity recognition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient)
  • Age 18 or older
  • Able and willing to give written consent and comply with study procedures

Exclusion Criteria

  • Serious cardiac conditions or neurological degenerative pathologies as co-morbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
  • Pregnant or nursing
  • Skin allergies or irritation; open wounds
  • Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254484


Contacts
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Contact: Vineet M Arora, MD MA 7737028157 varora@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Contact: Arun Jayaraman, PhD    312-298-6875    ajayaraman@ricres.org   
Principal Investigator: Arun Jayaraman, PhD         
Sponsors and Collaborators
University of Chicago
Shirley Ryan AbilityLab
Northwestern University

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04254484    
Other Study ID Numbers: SIESTA-Rehab
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders