SIESTA (Sleep of Inpatients: Empower Staff to Act) for Acute Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in total sleep time as measured by Actigraphy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
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.
干预措施: SIESTA Rehab Education (Behavioral)
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.
干预措施: ApneaLink (Diagnostic Test)
结局指标
主要结局
Change in total sleep time as measured by Actigraphy
时间窗: Overnight for first and last three nights of their stay. Average length of stay is 17 days.
Small multi-modality research-grade, wireless, and wearable sensors (Philips Actiwatch and Actigraph wGT3X-BT) are used to calculate total sleep time.
Quality Indicator (QI) Score
时间窗: Up to 3 months
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.
Karolinska Sleep Diary
时间窗: Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
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.
Modified Potential Disruptions of Hospital Sleep Questionnaire (PDHSQ)
时间窗: Daily during inpatient stay starting with study admission. Average length of stay is 17 days.
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.
次要结局
- Electronic Chart Audit(Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.)
- CPAP Adherence(Throughout 3 months of follow-up)
- Apnea Hypopnea Index (AHI)(One night around admission to the study.)
- Insomnia Severity Index(baseline upon study admission)
- Gait Analysis(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)
- Montreal Cognitive Assessment (MoCA)(Performed once near admission to study)
- Wearable Sensor Platform Measures of Change in Daytime Activity(Continuously during inpatient stay starting with study admission. Average length of stay is 17 days.)
- Change in wake after sleep onset time as measured by actigraphy(Overnight for first and last three nights of their stay. Average length of stay is 17 days.)
- 6-Minute Walk Test with VO2 analysis (6MWT)(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)
- Berg Balance Scale (BBS)(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)
- Wearable Sensor Platform Measures of Change in Sleep Staging(First three nights at study admission and last three nights before discharge.)
- Stroke characteristics(baseline upon study admission)
- Pharmacologic sleep aids(baseline upon study admission)
- 10-Meter Walk Test (10MWT)(Within 7 days; Within 7 days of Discharge; at 1-month post discharge, 2-month post discharge, and 3-month post discharge)
- Timed Up and Go (TUG)(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)
- Change in sleep efficiency as measured by actigraphy(Overnight for first and last three nights of their stay. Average length of stay is 17 days.)