SIESTA for Acute Stroke Rehabilitation — SIESTA-Rehab  

Stroke Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The SIESTA-Rehabilitation protocol combines two sleep-promoting interventions, (1) empowering nurses to reduce unnecessary disruptions and (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing, to determine its impact on relevant sleep and rehabilitation outcomes in the acute inpatient stroke rehabilitation setting compared to the standard of care. Our primary outcome is change in Quality Indicator (QI) score, a measure that has replaced the Functional Independence Measure (FIM) in the inpatient setting at the Shirley Ryan AbilityLab, between admission and discharge.

Clinical Trial Description

This study aims to determine the effectiveness of the SIESTA-Rehab protocol compared to usual care on inpatient sleep and stroke rehabilitation measures.

One inpatient floor will be chosen to receive the SIESTA protocol, while another floor will continue providing the standard of care. Floors will be asked not to speak about the protocol with other floors. It is highly unlikely that there would be crossover in personnel between the two floors and therefore we do not believe contamination will occur. Upon admission, patients are assigned to one of the two floors based on bed availability. The SIESTA-Rehab protocol consists of two parts. First, nurses will be educated and empowered to reduce unnecessary disruptions. This will begin with an informational video on common disruptions facing inpatients, and then staff will be introduced to techniques to minimize sleep disruptions such as batching medical tasks, less frequent nighttime visits, dimming lights, shutting doors, and reducing staff conversation. A SIESTA checklist for staff will also be utilized and SIESTA-Rehab Posters and Badge Cards will remind staff to practice these strategies. The Batched Care Protocol will be implemented with routine educational reminders and nudges for the nursing staff. Second, all patients on the intervention floor will be screened for sleep-disordered breathing using ApneaLink devices. Based on interpretation from the research team's sleep specialist, patients will be provided a treatment plan if necessary. The standard of care floor will serve as a control unit in which nursing care will continue as usual without any interventions to promote sleep and with routine screening for sleep disorders based on clinician judgment (current rates of stroke patients receiving a sleep study are less than 10%).

First aim is to determine subjective measures of sleep quality disruptions, objective nocturnal sleep disruptions, and objectively-measured sleep including duration, efficiency, and Wake After Sleep Onset (WASO). These objective and subjective measures will be collected during the participant's inpatient stay using the Karolinska Sleep Diary, the Modified Potential Disruptions of Hospital Sleep Questionnaire, electronic chart audit, the Apnea-Hypopnea Index, the Insomnia Severity Index, and through various wearable sensors.

Additionally, the study aims to determine if there exist differences in traditional measures of stroke recovery plus novel measures of activity and exercise tolerance using wearable sensors during inpatient rehabilitation in the SIESTA-Rehab protocol compared to the standard of care. The investigators will measure various activity outcomes throughout the course of the inpatient stay and during a 3-month period following discharge from the hospital to determine whether the SIESTA-Rehab protocol improves activity measures compared to usual care. These measures include the 6-Minute Walk Test with VO2 analysis, the 10-Meter Walk Test, the Berg Balance Scale, the Timed Up and Go test, the Manual Muscle Test, spatiotemporal parameters of gait using the GaitRite system, and the Action Research Arm Test.

Finally, the aim is to determine the effects of the SIESTA-Rehabilitation protocol on sleep, physical activity, and functional performance at home for up to 3-months after discharge from inpatient rehabilitation. Wearable sensors will collect data throughout the home follow-up period, and physical activity and performance outcomes will be measured at discharge and again at 1-month, 2-month, and 3-month follow-up visits. ;

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-Disordered Breathing
• Stroke

• NCT number: NCT04536623
• Study type: Interventional
• Source: Shirley Ryan AbilityLab
• Contact: Arun Jayaraman, PT, PhD
• Phone: (312) 238-6875
• Email: ajayaraman@ricres.org
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2020
• Completion date: May 2025