RECRUITING

The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

Quick Facts

Study Start:2021-03-25
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05012605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age 18 or older.
  3. * Admitted to in-patient rehabilitation.
  4. * 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).
  5. * Provision of informed consent by individual or by legally authorized representative.
  1. * Pre-stroke or current diagnosis of OSA or other sleep-related breathing disorder.
  2. * Living in a nursing home or assisted living center prior to the stroke.
  3. * Unable to ambulate 150' independently prior to the stroke.
  4. * Other neurologic health condition that may impact recovery such as Parkinson Disease, Multiple Sclerosis, Traumatic Brain Injury, Alzheimer's Disease.
  5. * Women who are pregnant.
  6. * 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.
  7. * Planned discharge location \>150 miles radius from recruitment site
  8. * Global aphasia as defined by a NIHSS item 9 score of 3 (3= Mute, global aphasia; no usable speech or auditory comprehension).
  9. * Inability to understand English

Contacts and Locations

Study Contact

Karen J Klingman, PhD
CONTACT
315-464-4276
klingmak@upstate.edu

Principal Investigator

Karen J Klingman, PhD
PRINCIPAL_INVESTIGATOR
SUNY Upstate Medical University, College of Nursing

Study Locations (Sites)

Emory University
Atlanta, Georgia, 39322
United States
KU Medical Center, The University of Kansas
Kansas City, Kansas, 66160
United States
Institute for Human Performance - Upstate Rehabilitation at IHP
Syracuse, New York, 13210
United States
Upstate University Hospital
Syracuse, New York, 13210
United States
Upstate Community Hospital
Syracuse, New York, 13215
United States
Good Shepherd Rehabilitation Network
Allentown, Pennsylvania, 17193
United States

Collaborators and Investigators

Sponsor: State University of New York - Upstate Medical University

  • Karen J Klingman, PhD, PRINCIPAL_INVESTIGATOR, SUNY Upstate Medical University, College of Nursing

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-25
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-03-25
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Longitudinal study
  • actigraphy
  • spatial analysis
  • patient reported outcome measures
  • wearable electronic devices

Additional Relevant MeSH Terms

  • Stroke
  • Sleep Wake Disorders
  • Rehabilitation
  • Recovery of Function