RecruitingNCT05012605

The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation


Sponsor

State University of New York - Upstate Medical University

Enrollment

200 participants

Start Date

Mar 25, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

OTHERObservation

Observe physical function and sleep disorder symptoms following stroke


Locations(6)

Emory University

Atlanta, Georgia, United States

KU Medical Center, The University of Kansas

Kansas City, Kansas, United States

Institute for Human Performance - Upstate Rehabilitation at IHP

Syracuse, New York, United States

Upstate University Hospital

Syracuse, New York, United States

Upstate Community Hospital

Syracuse, New York, United States

Good Shepherd Rehabilitation Network

Allentown, Pennsylvania, United States

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NCT05012605


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