The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Level of disability according to the stroke impact scale
研究概览
简要总结
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. The proposed study aims to characterize the proportion of people with stroke that have non-OSA sleep disorders and their impact on recovery of activities of daily living, functional mobility, and participation along the continuum of recovery in people with stroke.
详细描述
The overall goal in this project is to develop an in-depth understanding of the complex interplay between non-obstructive sleep apnea (non OSA) sleep disorders and recovery after stroke. Sleep is vital to overall health and quality of life. Abnormal or insufficient sleep is both a risk factor and consequence of stroke. Sleep also plays a critical role in motor learning, which is the foundation of rehabilitation strategies after stroke. Although there is a growing understanding of the interplay between sleep, stroke, and recovery in people with OSA these complex relationships in individuals post stroke with non OSA sleep disorders are not well understood. In order to develop targeted sleep interventions to support rehabilitation after stroke and promote optimal recovery, it is critical to gain a fuller understanding of the prevalence and impact of non OSA sleep disorders in people with stroke across the continuum of recovery. The specific objectives of this proposal will lay the necessary groundwork for this as investigators will characterize the proportion of people with stroke that have insomnia disorders, restless legs syndrome, and insufficient sleep; and evaluate the impact of these non OSA sleep disorders on recovery of activities of daily living, mobility/activity, and participation across the continuum of recovery after stroke. The study will take an innovative approach to measuring sleep, mobility/activity, and participation using a combination of techniques across the measurement spectrum that will include self-report questionnaires, clinic-based measures of capacity, and body worn sensors. The body worn sensors will include actigraphy to measure sleep parameters, activity monitors to measure mobility/activity levels, and Global Positioning System (GPS) units to measure participation. Additionally, investigators will apply innovative, big data tools from topological data analysis for a data driven approach to discover complex, structural, non-linear interdependent relationships among stroke, sleep, and recovery of mobility/activity, and participation. Upon completion of this study there will be an understanding of the prevalence and impact of non-OSA sleep disorders on recovery of function, mobility/activity, and participation across the continuum of recovery post stroke. This is an important, necessary step to develop appropriate sleep-based interventions to complement targeted rehabilitation strategies to enhance the health and quality of life in people with stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of stroke as defined by the WHO: "a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function and persisting longer than 24 hours." Diagnosis of stroke will be confirmed by imaging or clinical diagnosis.
- •Age 18 or older.
- •Admitted to in-patient rehabilitation.
- •National Institutes of Health Stroke Scale (NIHSS) item 1a score <2 (Level of consciousness: 0=alert, 1=not alert, but arousable by minor stimulation to obey, answer, or respond).
- •Provision of informed consent by individual or by legally authorized representative.
排除标准
- •Pre-stroke or current diagnosis of OSA or other sleep-related breathing disorder.
- •Living in a nursing home or assisted living center prior to the stroke.
- •Unable to ambulate 150' independently prior to the stroke.
- •Other neurologic health condition that may impact recovery such as Parkinson Disease, Multiple Sclerosis, Traumatic Brain Injury, Alzheimer's Disease.
- •Women who are pregnant.
- •Recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure.
- •Planned discharge location >150 miles radius from recruitment site
- •Global aphasia as defined by a NIHSS item 9 score of 3 (3= Mute, global aphasia; no usable speech or auditory comprehension).
- •Inability to understand English
结局指标
主要结局
Level of disability according to the stroke impact scale
时间窗: 90 days post-stroke
The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function
Daytime sleepiness according to the Epworth Sleepiness Scale
时间窗: 90 days post-stroke
Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness
Functional independence with activities of daily living as measured by the Barthel index
时间窗: 90 days post-stroke
The Barthel index is a measure of functional independence with activities of daily living; the score ranges 0-100 with higher numbers indicating more independence
Insomnia severity as determined from the insomnia severity index
时间窗: 90 days post-stroke
The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia
Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
时间窗: 90 days post-stroke
The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.
Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
时间窗: 90 days post-stroke
The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.
次要结局
- Degree of disability according to the modified Rankin scale(90 days post-stroke)
- Gait speed(90 days post-stroke)
- Cognitive ability according to the Montreal cognitive assessment(90 days post-stroke)
- Types of community locations visited by study participants, as determined from global positioning sensor data(90 days post-stroke)
- GG code for Mobility and Self Care Sections(15 days post-stroke)
- Depression severity as measured by the patient health questionnaire (9-item version)(90 days post-stroke)
- Wrist actigraphy data(90 days post-stroke)
- Balance ability according to the Berg balance scale(90 days post-stroke)
- Activity level(90 days post-stroke)
- Daily activities as recorded by study participants (trip log)(90-days post-stroke)
- Sleep diary(90 days post-stroke)
- Oxygen desaturation index(15 days post-stroke)
研究者
Karen J. Klingman PhD RN
Associate Professor
State University of New York - Upstate Medical University