SIESTA for Acute Stroke Rehabilitation

Stroke Clinical Trial

— SIESTA-Rehab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536623
• Other study ID #: STU00211695
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: May 2025

Study information

• Verified date: February 2022
• Source: Shirley Ryan AbilityLab
• Contact: Arun Jayaraman, PT, PhD
• Phone: (312) 238-6875
• Email: ajayaraman[@]ricres.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The SIESTA-Rehabilitation protocol combines two sleep-promoting interventions, (1) empowering nurses to reduce unnecessary disruptions and (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing, to determine its impact on relevant sleep and rehabilitation outcomes in the acute inpatient stroke rehabilitation setting compared to the standard of care. Our primary outcome is change in Quality Indicator (QI) score, a measure that has replaced the Functional Independence Measure (FIM) in the inpatient setting at the Shirley Ryan AbilityLab, between admission and discharge.

Description:

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

One inpatient floor will be chosen to receive the SIESTA protocol, while another floor will continue providing the standard of care. Floors will be asked not to speak about the protocol with other floors. It is highly unlikely that there would be crossover in personnel between the two floors and therefore we do not believe contamination will occur. Upon admission, patients are assigned to one of the two floors based on bed availability. The SIESTA-Rehab protocol consists of two parts. First, nurses will be educated and empowered to reduce unnecessary disruptions. This will begin with an informational video on common disruptions facing inpatients, and then staff will be introduced to techniques to minimize sleep disruptions such as batching medical tasks, less frequent nighttime visits, dimming lights, shutting doors, and reducing staff conversation. A SIESTA checklist for staff will also be utilized and SIESTA-Rehab Posters and Badge Cards will remind staff to practice these strategies. The Batched Care Protocol will be implemented with routine educational reminders and nudges for the nursing staff. Second, all patients on the intervention floor will be screened for sleep-disordered breathing using ApneaLink devices. Based on interpretation from the research team's sleep specialist, patients will be provided a treatment plan if necessary. The standard of care floor will serve as a control unit in which nursing care will continue as usual without any interventions to promote sleep and with routine screening for sleep disorders based on clinician judgment (current rates of stroke patients receiving a sleep study are less than 10%).

First aim is to determine subjective measures of sleep quality disruptions, objective nocturnal sleep disruptions, and objectively-measured sleep including duration, efficiency, and Wake After Sleep Onset (WASO). These objective and subjective measures will be collected during the participant's inpatient stay using the Karolinska Sleep Diary, the Modified Potential Disruptions of Hospital Sleep Questionnaire, electronic chart audit, the Apnea-Hypopnea Index, the Insomnia Severity Index, and through various wearable sensors.

Additionally, the study aims to determine if there exist differences in traditional measures of stroke recovery plus novel measures of activity and exercise tolerance using wearable sensors during inpatient rehabilitation in the SIESTA-Rehab protocol compared to the standard of care. The investigators will measure various activity outcomes throughout the course of the inpatient stay and during a 3-month period following discharge from the hospital to determine whether the SIESTA-Rehab protocol improves activity measures compared to usual care. These measures include the 6-Minute Walk Test with VO2 analysis, the 10-Meter Walk Test, the Berg Balance Scale, the Timed Up and Go test, the Manual Muscle Test, spatiotemporal parameters of gait using the GaitRite system, and the Action Research Arm Test.

Finally, the aim is to determine the effects of the SIESTA-Rehabilitation protocol on sleep, physical activity, and functional performance at home for up to 3-months after discharge from inpatient rehabilitation. Wearable sensors will collect data throughout the home follow-up period, and physical activity and performance outcomes will be measured at discharge and again at 1-month, 2-month, and 3-month follow-up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient)

• medical clearance from physician

• 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 comorbidities (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)

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-Disordered Breathing
• Stroke

Intervention

Behavioral:
• SIESTA-Rehab Protocol
Inpatient floor assigned to SIESTA-Rehab protocol. Nurses trained to follow batched care protocol and use SIESTA-Rehab staff checklist. Patients are screened for sleep-disordered breathing using ApneaLink device and treated accordingly.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Northwestern University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality Indicator (QI) score	The QI score is a measure used in the inpatient setting at the Shirley Ryan AbilityLab that has replaced the Functional Independence Measure (FIM). The score can be obtained in all patients, regardless of stroke type or deficit. The QI evaluates level of disability, and how much assistance is needed for a subject to perform activities of daily living. Each item is scored ranging from total assistance to total independence. Items include eating, grooming, bathing, dressing, toiling, bladder/bowel management, transfers, locomotion, stairs, comprehension, etc.	Change from Baseline QI at discharge. Average length of stay is 17 days.
Secondary	Actigraphy Measures of Sleep Quality	These small, rugged, actigraphy-based data loggers record a digitally integrated measure of gross motor activity using a highly sensitive accelerometer to calculate objective measures of sleep quality. 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 graphically as actograms. The Philips Actiwatch can record up to 60 days using 30-second epochs or until data is downloaded. Actigrpahy data can be analyzed to determine sleep duration, sleep efficiency, and WASO. The Phillips Actiwatch will be worn on the non-dominant wrist, unless that arm has limited mobility, in which case the other wrist will be used.	Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Wearable Sensor Platform Measures of Sleep Quality	Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of sleep quality. The MC10 can be placed simultaneously on body locations, collecting accelerometer, gyroscope, and bio-potential sensor data to provide a more in-depth analysis of heart rate variability across the night. The ActiGraph and ActiLink can be worn on the wrist or waist to collect accelerometer, gyroscope, and magnetometer data as well as light data to determine the brightness of the room. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted in a measure of sleep latency (how many minutes it takes to fall asleep)	Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Wearable Sensor Platform Measures of Sleep Quality	Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of sleep quality. The MC10 can be placed simultaneously on body locations, collecting accelerometer, gyroscope, and bio-potential sensor data to provide a more in-depth analysis of heart rate variability across the night. The ActiGraph and ActiLink can be worn on the wrist or waist to collect accelerometer, gyroscope, and magnetometer data as well as light data to determine the brightness of the room. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted in a measure of sleep efficiency (how many minutes awake divided how many minutes in bed).	Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Wearable Sensor Platform Measures of Sleep Quality	Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of sleep quality. The MC10 can be placed simultaneously on body locations, collecting accelerometer, gyroscope, and bio-potential sensor data to provide a more in-depth analysis of heart rate variability across the night. The ActiGraph and ActiLink can be worn on the wrist or waist to collect accelerometer, gyroscope, and magnetometer data as well as light data to determine the brightness of the room. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted in a measure of sleep duration (how many minutes asleep)	Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Wearable Sensor Platform Measures of Sleep Quality	Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of sleep quality. The MC10 can be placed simultaneously on body locations, collecting accelerometer, gyroscope, and bio-potential sensor data to provide a more in-depth analysis of heart rate variability across the night. The ActiGraph and ActiLink can be worn on the wrist or waist to collect accelerometer, gyroscope, and magnetometer data as well as light data to determine the brightness of the room. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted in a measure of wake after sleep onset (how many minutes after the sleep onset latency awake)	Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Wearable Sensor Platform Measures of Daytime Activity	Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of sleep quality. The MC10 can be placed simultaneously on body locations, collecting accelerometer, gyroscope, and bio-potential sensor data to provide a more in-depth analysis of heart rate variability across the night. The ActiGraph and ActiLink can be worn on the wrist or waist to collect accelerometer, gyroscope, and magnetometer data as well as light data to determine the brightness of the room. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted in a measure of step count.	Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Karolinska Sleep Diary	This questionnaire calculates the sleep quality index (SQI) using four items: slept throughout, sleep restless, ease falling asleep, and premature awakenings. A higher SQI indicates better sleep quality. Additionally, three items (ease awakening, refreshed, sufficient sleep) yield an awake score with lower scores indicating better sleep. Items have 5-point verbal anchors, and response alternatives vary with each question. It has been correlated with measures from polysomnography to measure sleep quality the night prior to administration.	Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Modified Potential Disruptions of Hospital Sleep Questionnaire (PDHSQ)	This subjective questionnaire asks inpatients how specific items disrupted their sleep the prior night from 1 (not disruptive) to 5 (extremely disruptive). Select items correlate with in-hospital actigraphy, and specific items address rehabilitation.	Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Electronic Chart Audit	We will obtain objective baseline data on orders of nighttime vitals, nocturnal medications that disrupt sleep (heparin q8, nighttime medications, bathing, etc.).	Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Apnea-hypopnea index (AHI)	ApneaLink is a simple, cost-effective, portable device for diagnosing sleep-disordered breathing. The device automatically analyzes and derives an AHI score, flow limitation, snoring information, and oxygen desaturation index. An expert sleep specialist will review the analysis to ensure correct interpretation. Models using time below 90% oxygen or oxygen desaturation index will be considered as a replacement for AHI.	Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
Secondary	Stroke Characteristics	Because stroke characteristics can impact sleep, we will obtain participant data about type of stroke (hemorrhagic/ischemic), stroke location (per CT), stroke deficits (urinary incontinence, aphasia, etc.), stroke severity (based on the NIH Stroke Scale), and presence of recurrent stroke (obtained from chart audit).	Baseline (upon study admission)
Secondary	Insomnia Severity Index	This questionnaire is a 7-item validated screening tool designed to asses the nature, severity, and impact of insomnia in adults.	Baseline (upon study admission)
Secondary	Pharmacologic Sleep Aids	Using the electronic health record and a previously developed University of Chicago chart abstraction tool, a percentage of pharmacologic sleep aids used will be calculated.	Baseline (upon study admission)
Secondary	CPAP Adherence	For patients utilizing a CPAP, device adherence will be collected wirelessly through the device modem.	Throughout 3 months of follow-up
Secondary	6-Minute Walk Test with VO2 analysis (6MWT)	The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in 6 minutes, using assistive devices as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change for people with sub-acute stroke is 60.98 meters.	Baseline; Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post dischargeMidpoint; Discharge; 1-month, 2-month, and 3-month follow up visits
Secondary	10-Meter Walk Test (10MWT)	The 10MWT measures the amount of time it takes to walk 10 meters. Time will be recorded using a stopwatch and recorded to the one hundredth of a second. The effects of acceleration and deceleration are minimized by adding 1 meter at the beginning and end of the course to isolate the subject's steady state speed. The test will be recorded 3 times each at a normal self-selected pace and at a faster pace, with adequate rest in between. Results will be averaged from 3 trials. Any assistive devices or orthotics should be kept consistent throughout and documented.	Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post discharge
Secondary	Berg Balance Scale (BBS)	The BBS is a 14-item test, scored on a 5-level ordinal scale and validated against length of stay and discharge destination for stroke patients. It measures functional balance in a clinical setting during static and dynamic tasks (sitting, standing, transitioning from sit to stand, etc.).	Baseline; Midpoint; Discharge; 1Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post discharge-month, 2-month, and 3-month follow up visits
Secondary	Timed Up and Go (TUG)	The TUG assesses mobility by measuring the time a person take to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. It can detect longitudinal changes in mobility in stroke patients. The subject wears their routine footwear and orthotics and can use their mobility aids.	Baseline; Midpoint; DiscWithin 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post dischargeharge; 1-month, 2-month, and 3-month follow up visits
Secondary	Gait Analysis	Gait analysis provides a quantitative means of assessing walking function based on spatiotemporal parameters of gait. Subjects walk at both a comfortable and a fast pace over the GaitRite system, an electronic walkway with integrated sensors. Data from GaitRite is reliable and valid for evaluating walking characteristics and provides a gold standard for validating gait parameters from the sensors. For gait analysis, we will focus on 5 parameters: stride time, swing time, stance time, step length, and cadence.	Baseline; Midpoint; Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post dischargeDischarge; 1-month, 2-month, and 3-month follow up visits
Secondary	Montreal Cognitive Assessment (MoCA)	The 10-item MoCA assesses several cognitive domains. These include short-term memory recall, visuospatial abilities, executive function, attention, concentration, language and orientation to time and place.	Baseline; Midpoint; Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post dischargeDischarge; 1-month, 2-month, and 3-month follow up visits