Clinical trial NCT04254484: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep
Sleep Disordered Breathing
Stroke
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
name: Northwestern University
First posted: 2020-02-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Quality Indicator (QI) Score
timeFrame: Up to 3 months
measure: Karolinska Sleep Diary
timeFrame: Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
measure: Modified Potential Disruptions of Hospital Sleep Questionnaire (PDHSQ)
timeFrame: Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
measure: Change in total sleep time as measured by Actigraphy
timeFrame: Overnight for first and last three nights of their stay. Average length of stay is 17 days.
Secondary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: One night around admission to the study.
measure: Electronic Chart Audit
timeFrame: Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
measure: Insomnia Severity Index
timeFrame: baseline upon study admission
measure: Stroke characteristics
timeFrame: baseline upon study admission
measure: Pharmacologic sleep aids
timeFrame: baseline upon study admission
measure: CPAP Adherence
timeFrame: Throughout 3 months of follow-up
measure: 6-Minute Walk Test with VO2 analysis (6MWT)
timeFrame: 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
measure: 10-Meter Walk Test (10MWT)
timeFrame: Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post discharge
measure: Berg Balance Scale (BBS)
timeFrame: 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
measure: Timed Up and Go (TUG)
timeFrame: 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
measure: Gait Analysis
timeFrame: 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
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Performed once near admission to study
measure: Wearable Sensor Platform Measures of Change in Sleep Staging
timeFrame: First three nights at study admission and last three nights before discharge.
measure: Wearable Sensor Platform Measures of Change in Daytime Activity
timeFrame: Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.
measure: Change in wake after sleep onset time as measured by actigraphy
timeFrame: Overnight for first and last three nights of their stay. Average length of stay is 17 days.
measure: Change in sleep efficiency as measured by actigraphy
timeFrame: Overnight for first and last three nights of their stay. Average length of stay is 17 days.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: