Understanding how sleep affects recovery after stroke
The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
This study looks at how sleep problems affect recovery for people who have had a stroke to see if better sleep can help them get back to their daily activities and rehab more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State University of New York - Upstate Medical University Academic / other |
| Locations | 6 sites (Atlanta, Georgia and 5 other locations) |
| Trial ID | NCT05012605 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the prevalence and impact of non-obstructive sleep apnea (non-OSA) sleep disorders in individuals recovering from stroke. By utilizing a combination of actigraphy, spatial analysis, and patient-reported outcome measures, the study will assess how these sleep disorders influence daily living activities, functional mobility, and overall participation in rehabilitation. The research will focus on characterizing the types of sleep disorders present and their effects on recovery, providing insights that could lead to targeted interventions for improving rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with stroke and are currently admitted to in-patient rehabilitation.
Not a fit: Patients with pre-existing obstructive sleep apnea or other sleep-related breathing disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for stroke patients by addressing sleep disorders that hinder recovery.
How similar studies have performed: While there is growing research on sleep disorders in stroke patients, this specific focus on non-OSA sleep disorders is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 5 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- KU Medical Center, The University of Kansas — Kansas City, Kansas, United States (Recruiting)
- Institute for Human Performance - Upstate Rehabilitation at IHP — Syracuse, New York, United States (Active_not_recruiting)
- Upstate University Hospital — Syracuse, New York, United States (Recruiting)
- Upstate Community Hospital — Syracuse, New York, United States (Suspended)
- Good Shepherd Rehabilitation Network — Allentown, Pennsylvania, United States (Terminated)
Study contacts
- Principal investigator: Karen J Klingman, PhD — SUNY Upstate Medical University, College of Nursing
- Study coordinator: Karen J Klingman, PhD
- Email: klingmak@upstate.edu
- Phone: 315-464-4276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.