Clinical trial NCT05012605: The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
Official title: The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Sleep Wake Disorders
Rehabilitation
Recovery of Function
Keywords: Longitudinal study
actigraphy
spatial analysis
patient reported outcome measures
wearable electronic devices
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults recovering from stroke within the first 90 days following stroke who did not have a diagnosis of obstructive sleep apnea (OSA) prior to stroke or who do not have oxygen desaturation index (ODI) of 15 or higher during inpatient rehabilitation (\~15 days post-stroke).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Functional independence with activities of daily living as measured by the Barthel index
timeFrame: 15 days post-stroke
measure: Functional independence with activities of daily living as measured by the Barthel index
timeFrame: 60 days post-stroke
measure: Functional independence with activities of daily living as measured by the Barthel index
timeFrame: 90 days post-stroke
measure: Level of disability according to the stroke impact scale
timeFrame: 60 days post-stroke
measure: Level of disability according to the stroke impact scale
timeFrame: 90 days post-stroke
measure: Daytime sleepiness according to the Epworth Sleepiness Scale
timeFrame: 15 days post-stroke
measure: Daytime sleepiness according to the Epworth Sleepiness Scale
timeFrame: 60 days post-stroke
measure: Daytime sleepiness according to the Epworth Sleepiness Scale
timeFrame: 90 days post-stroke
measure: Insomnia severity as determined from the insomnia severity index
timeFrame: 15 days post-stroke
measure: Insomnia severity as determined from the insomnia severity index
timeFrame: 60 days post-stroke
measure: Insomnia severity as determined from the insomnia severity index
timeFrame: 90 days post-stroke
measure: Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
timeFrame: 15 days post-stroke
measure: Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
timeFrame: 60 days post-stroke
measure: Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire
timeFrame: 90 days post-stroke
measure: Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
timeFrame: 15days post-stroke
measure: Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
timeFrame: 60days post-stroke
measure: Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version
timeFrame: 90 days post-stroke
Secondary outcomes:
measure: Degree of disability according to the modified Rankin scale
timeFrame: 15 days post-stroke
measure: Degree of disability according to the modified Rankin scale
timeFrame: 60 days post-stroke
measure: Degree of disability according to the modified Rankin scale
timeFrame: 90 days post-stroke
measure: Balance ability according to the Berg balance scale
timeFrame: 15 days post-stroke
measure: Balance ability according to the Berg balance scale
timeFrame: 60 days post-stroke
measure: Balance ability according to the Berg balance scale
timeFrame: 90 days post-stroke
measure: Gait speed
timeFrame: 15 days post-stroke
measure: Gait speed
timeFrame: 60 days post-stroke
measure: Gait speed
timeFrame: 90 days post-stroke
measure: Activity level
timeFrame: 15 days post-stroke
measure: Activity level
timeFrame: 60 days post-stroke
measure: Activity level
timeFrame: 90 days post-stroke
measure: Types of community locations visited by study participants, as determined from global positioning sensor data
timeFrame: 60 days post-stroke
measure: Types of community locations visited by study participants, as determined from global positioning sensor data
timeFrame: 90 days post-stroke
measure: GG code for Mobility and Self Care Sections
timeFrame: 15 days post-stroke
measure: Daily activities as recorded by study participants (trip log)
timeFrame: 60-days post-stroke
measure: Daily activities as recorded by study participants (trip log)
timeFrame: 90-days post-stroke
measure: Cognitive ability according to the Montreal cognitive assessment
timeFrame: 15 days post-stroke
measure: Cognitive ability according to the Montreal cognitive assessment
timeFrame: 60 days post-stroke
measure: Cognitive ability according to the Montreal cognitive assessment
timeFrame: 90 days post-stroke
measure: Depression severity as measured by the patient health questionnaire (9-item version)
timeFrame: 15 days post-stroke
measure: Depression severity as measured by the patient health questionnaire (9-item version)
timeFrame: 60 days post-stroke
measure: Depression severity as measured by the patient health questionnaire (9-item version)
timeFrame: 90 days post-stroke
measure: Sleep diary
timeFrame: 60 days post-stroke
measure: Sleep diary
timeFrame: 90 days post-stroke
measure: Oxygen desaturation index
timeFrame: 90 days post-stroke
measure: Oxygen desaturation index
timeFrame: 60 days post-stroke
measure: Oxygen desaturation index
timeFrame: 15 days post-stroke
measure: Wrist actigraphy data
timeFrame: 15 days post-stroke
measure: Wrist actigraphy data
timeFrame: 60 days post-stroke
measure: Wrist actigraphy data
timeFrame: 90 days post-stroke
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Kansas City
country: United States
facility: KU Medical Center, The University of Kansas
state: Kansas
city: Syracuse
country: United States
facility: Institute for Human Performance - Upstate Rehabilitation at IHP
state: New York
city: Syracuse
country: United States
facility: Upstate University Hospital
state: New York
city: Syracuse
country: United States
facility: Upstate Community Hospital
state: New York
city: Allentown
country: United States
facility: Good Shepherd Rehabilitation Network
state: Pennsylvania
Study officials:
affiliation: SUNY Upstate Medical University, College of Nursing
name: Karen J Klingman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klingman KJ, Skufca JD, Duncan PW, Wang D, Fulk GD. Study Protocol: Sleep Effects on Poststroke Rehabilitation Study. Nurs Res. 2022 Nov-Dec 01;71(6):483-490. doi: 10.1097/NNR.0000000000000611. Epub 2022 Aug 6.