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

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The University of Chicago

Status

Invitation-only

Conditions

Stroke
Sleep Disordered Breathing
Sleep

Treatments

Behavioral: SIESTA Rehab Education
Diagnostic Test: ApneaLink

Study type

Interventional

Funder types

Other

Identifiers

NCT04254484
SIESTA-Rehab

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

SIESTA Rehab
Experimental group
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.
Treatment:
Diagnostic Test: ApneaLink
Behavioral: SIESTA Rehab Education
Control Unit
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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