The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

Status unconfirmed

Conditions studied: Stroke, Sleep Wake Disorders, Rehabilitation, Recovery of Function

In brief

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.

Key facts

Study ID

NCT05012605

Run by

State University of New York - Upstate Medical University

People needed

200

Starts

2021-03-25

Expected to finish

2025-06-30

Last updated by the study team

2024-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Emory University — Atlanta, Georgia, United States (enrolling)
• KU Medical Center, The University of Kansas — Kansas City, Kansas, United States (enrolling)
• Upstate University Hospital — Syracuse, New York, United States (enrolling)
• Institute for Human Performance - Upstate Rehabilitation at IHP — Syracuse, New York, United States
• Upstate Community Hospital — Syracuse, New York, United States
• Good Shepherd Rehabilitation Network — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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