The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

Last updated: May 21, 2024
Sponsor: State University of New York - Upstate Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Observation

Clinical Study ID

NCT05012605
R01NR018979
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of stroke as defined by the WHO: "a rapid onset event of vascular originreflecting a focal disturbance of cerebral function, excluding isolated impairmentsof higher function and persisting longer than 24 hours." Diagnosis of stroke will beconfirmed 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 ofconsciousness: 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

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 ParkinsonDisease, Multiple Sclerosis, Traumatic Brain Injury, Alzheimer's Disease.

  • Women who are pregnant.

  • Recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has notyet been replaced), or any other recent bone removal procedure for relief ofintracranial 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; nousable speech or auditory comprehension).

  • Inability to understand English

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Observation
Phase:
Study Start date:
March 25, 2021
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Emory University

    Atlanta, Georgia 39322
    United States

    Active - Recruiting

  • KU Medical Center, The University of Kansas

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Institute for Human Performance - Upstate Rehabilitation at IHP

    Syracuse, New York 13210
    United States

    Site Not Available

  • Upstate Community Hospital

    Syracuse, New York 13215
    United States

    Suspended

  • Upstate University Hospital

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Good Shepherd Rehabilitation Network

    Allentown, Pennsylvania 17193
    United States

    Terminated

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