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

Primary Purpose

Sleep, Sleep Disordered Breathing, Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIESTA Rehab Education
ApneaLink
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 . Medical clearance from physician

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)

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SIESTA Rehab

Control Unit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in total sleep time as measured by Actigraphy
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total sleep time.

Secondary Outcome Measures

Apnea Hypopnea Index (AHI)
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
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.).
Insomnia Severity Index
This questionnaire is a 7-item validated screening tool designed to assess the nature, severity, and impact of insomnia in adults.
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).
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.
CPAP Adherence
For patients utilizing a CPAP, device adherence will be collected wirelessly through the device modem.
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.
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.
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.).
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.
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.
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.
Wearable Sensor Platform Measures of Change in Sleep Staging
Small multi-modality research-grade, wireless, and wearable sensors (eg. MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate REM cycles without the use of PPG. The MC10 or other wearable sensors 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. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke.
Wearable Sensor Platform Measures of Change in Daytime Activity
Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of activity. The MC10 can be placed simultaneously on body locations, and the ActiGraph and ActiLink are worn on the wrist, with all three collecting accelerometer and gyroscope data. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted into a measure of step count.
Change in wake after sleep onset time as measured by actigraphy
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total wake after sleep onset.
Change in sleep efficiency as measured by actigraphy
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total sleep efficiency.

Full Information

First Posted
March 27, 2018
Last Updated
August 18, 2022
Sponsor
University of Chicago
Collaborators
Shirley Ryan AbilityLab, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04254484
Brief Title
SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation
Official Title
SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Shirley Ryan AbilityLab, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Disordered Breathing, Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIESTA Rehab
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Unit
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SIESTA Rehab Education
Intervention Description
Staff nurses will be trained on how to improve sleep in stroke patients in the acute rehabilitation setting.
Intervention Type
Diagnostic Test
Intervention Name(s)
ApneaLink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality Indicator (QI) Score
Description
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.
Time Frame
Up to 3 months
Title
Karolinska Sleep Diary
Description
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.
Time Frame
Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
Title
Modified Potential Disruptions of Hospital Sleep Questionnaire (PDHSQ)
Description
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.
Time Frame
Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
Title
Change in total sleep time as measured by Actigraphy
Description
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total sleep time.
Time Frame
Overnight for first and last three nights of their stay. Average length of stay is 17 days.
Secondary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Description
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
Time Frame
One night around admission to the study.
Title
Electronic Chart Audit
Description
We will obtain objective baseline data on orders of nighttime vitals, nocturnal medications that disrupt sleep (heparin q8, nighttime medications, bathing, etc.).
Time Frame
Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Title
Insomnia Severity Index
Description
This questionnaire is a 7-item validated screening tool designed to assess the nature, severity, and impact of insomnia in adults.
Time Frame
baseline upon study admission
Title
Stroke characteristics
Description
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).
Time Frame
baseline upon study admission
Title
Pharmacologic sleep aids
Description
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.
Time Frame
baseline upon study admission
Title
CPAP Adherence
Description
For patients utilizing a CPAP, device adherence will be collected wirelessly through the device modem.
Time Frame
Throughout 3 months of follow-up
Title
6-Minute Walk Test with VO2 analysis (6MWT)
Description
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.
Time Frame
Baseline; Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post discharge Midpoint; Discharge; 1-month, 2-month, and 3-month follow up visits
Title
10-Meter Walk Test (10MWT)
Description
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.
Time Frame
Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post discharge
Title
Berg Balance Scale (BBS)
Description
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.).
Time Frame
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
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
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
Title
Gait Analysis
Description
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.
Time Frame
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
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Performed once near admission to study
Title
Wearable Sensor Platform Measures of Change in Sleep Staging
Description
Small multi-modality research-grade, wireless, and wearable sensors (eg. MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate REM cycles without the use of PPG. The MC10 or other wearable sensors 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. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke.
Time Frame
First three nights at study admission and last three nights before discharge.
Title
Wearable Sensor Platform Measures of Change in Daytime Activity
Description
Small multi-modality research-grade, wireless, and wearable sensors (MC10 Biostamp, ActiGraph, and ActiLink) will be used to calculate objective measures of activity. The MC10 can be placed simultaneously on body locations, and the ActiGraph and ActiLink are worn on the wrist, with all three collecting accelerometer and gyroscope data. Actigraph management and data analysis are done using SRALab machine learning algorithms specific to stroke. Raw acceleration data will be converted into a measure of step count.
Time Frame
Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
Title
Change in wake after sleep onset time as measured by actigraphy
Description
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total wake after sleep onset.
Time Frame
Overnight for first and last three nights of their stay. Average length of stay is 17 days.
Title
Change in sleep efficiency as measured by actigraphy
Description
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total sleep efficiency.
Time Frame
Overnight for first and last three nights of their stay. Average length of stay is 17 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 . Medical clearance from physician 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)
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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