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

NCT04254484 | Completed DMC

• 1 other identifier: SIESTA-Rehab
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Stroke; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 3 months

• 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.

• 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.

• 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.

  Overnight for first and last three nights of their stay. Average length of stay is 17 days.

Secondary Outcomes (16)

• Apnea Hypopnea Index (AHI)

  One night around admission to the study.

• Electronic Chart Audit

  Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.

• Insomnia Severity Index

  baseline upon study admission

• Stroke characteristics

  baseline upon study admission

• Pharmacologic sleep aids

  baseline upon study admission

Study Arms (2)

SIESTA Rehab

EXPERIMENTAL

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; Diagnostic Test: ApneaLink

Control Unit

NO 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.

Interventions

ApneaLink DIAGNOSTIC_TEST

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.

SIESTA Rehab

SIESTA Rehab Education BEHAVIORAL

Staff nurses will be trained on how to improve sleep in stroke patients in the acute rehabilitation setting.

SIESTA Rehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: collaborator
• Northwestern University: collaborator
• University of Chicago: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Sindorf J, Campagnini S, O'Brien MK, Sunderrajan A, Knutson KL, Zee PC, Wolfe L, Arora VM, Jayaraman A. Sleep Following a Stroke: Multimodal Evaluation of Sleep Health and Disruptions and Impact on Recovery During Acute Inpatient Rehabilitation. Neurorehabil Neural Repair. 2025 Jul;39(7):529-541. doi: 10.1177/15459683251335332. Epub 2025 May 6.

  PMID: 40326398 DERIVED

• Sindorf J, Szabo AL, O'Brien MK, Sunderrajan A, Knutson KL, Zee PC, Wolfe L, Arora VM, Jayaraman A. Wireless wearable sensors can facilitate rapid detection of sleep apnea in hospitalized stroke patients. Sleep. 2024 Nov 8;47(11):zsae123. doi: 10.1093/sleep/zsae123.

  PMID: 38814827 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Stroke

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: February 5, 2020
• Study Start: July 21, 2020
• Primary Completion: May 15, 2025
• Study Completion: July 14, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)