SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation
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|ClinicalTrials.gov Identifier: NCT04254484|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Sleep Disordered Breathing Stroke||Behavioral: SIESTA Rehab Education Diagnostic Test: ApneaLink||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: SIESTA Rehab
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
Staff nurses will be trained on how to improve sleep in stroke patients in the acute rehabilitation setting.
Diagnostic Test: ApneaLink
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.
No Intervention: Control Unit
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.
- Change in Sleep Duration [ Time Frame: Up to 6 months ]Actiwatches are small, rugged, actigraphy-based data loggers that record a digitally integrated measure of gross motor activity using a highly sensitive accelerometer. 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 as "Activity Counts" is recorded in onboard memory. Data may be expressed graphically as actograms. The Philips Actiwatch can record up to 60 days using 30-second epochs or until data is downloaded. Actigraphy data is analyzed using associated software (Actiware v5) which uses algorithms to determine sleep duration, sleep efficiency and wake after sleep onset (WASO).The Actiwatch will be worn on the non-dominant wrist, unless that arm has limited mobility, in which case the other wrist will be used.
- Change in Functional Independence Measure (FIM) Score [ Time Frame: Up to 6 months ]The FIM is an 18-item test (13 motor tasks, 5 cognitive tasks) for evaluating level of disability, and how much assistance is needed for a subject to perform certain activities of daily living. Each item is scored on a 7-point ordinal scale, ranging from total assistance (1) to total independence (7). Items include eating, grooming, bathing, dressing, toileting, bladder/bowel management, transfers, locomotion and stairs, comprehension, etc. The minimally clinical important difference for people with acute stroke is 22 points (17 on motor subscale, 3 on cognitive subscale). The FIM has been shown to be a valid predictor of outcome after discharge from rehabilitation in stroke patients.
- Apnea Hypopnea Index (AHI) [ Time Frame: 8 hours ]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
- Activity counts [ Time Frame: Up to 6 months ]As captured by actigraph GT9X worn around the waist. The specific parameters used to monitor mobility and clinical performance are step count, intensity, dose of rehabilitation, and activity recognition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254484
|Contact: Vineet M Arora, MD MAfirstname.lastname@example.org|
|United States, Illinois|
|Shirley Ryan AbilityLab|
|Chicago, Illinois, United States, 60611|
|Contact: Arun Jayaraman, PhD 312-298-6875 email@example.com|
|Principal Investigator: Arun Jayaraman, PhD|