The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

NCT ID: NCT05012605

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2025-06-30

Brief 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.

Detailed 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.

Conditions

Stroke; Sleep Wake Disorders; Rehabilitation; Recovery of Function

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SLEEPR cohort

Individuals within first 3 months following stroke who did not have obstructive sleep apnea within the first 15 days following stroke

Observation

Intervention Type: OTHER

Observe physical function and sleep disorder symptoms following stroke

Interventions

Observation

Observe physical function and sleep disorder symptoms following stroke

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Karen J. Klingman PhD RN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen J Klingman, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY Upstate Medical University, College of Nursing

Locations

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

KU Medical Center, The University of Kansas

Kansas City, Kansas, United States

Site Status: RECRUITING

Institute for Human Performance - Upstate Rehabilitation at IHP

Syracuse, New York, United States

Site Status: ACTIVE_NOT_RECRUITING

Upstate University Hospital

Syracuse, New York, United States

Site Status: RECRUITING

Upstate Community Hospital

Syracuse, New York, United States

Site Status: SUSPENDED

Good Shepherd Rehabilitation Network

Allentown, Pennsylvania, United States

Site Status: TERMINATED

Countries

United States

Central Contacts

Karen J Klingman, PhD

Role: CONTACT

klingmak@upstate.edu

315-464-4276

Facility Contacts

George D Fulk, PhD PT

Role: primary

404-727-9807

Sandra A Billinger, PhD

Role: primary

sbillinger@kumc.edu

913-588-5000

Karen J Klingman, PhD

Role: primary

klingmak@upstate.edu

315-464-4276

References

Klingman KJ, Skufca JD, Duncan PW, Wang D, Fulk GD. Study Protocol: Sleep Effects on Poststroke Rehabilitation Study. Nurs Res. 2022 Nov-Dec 01;71(6):483-490. doi: 10.1097/NNR.0000000000000611. Epub 2022 Aug 6.

Reference Type: DERIVED

PMID: 35948301 (View on PubMed)

Other Identifiers

R01NR018979

Identifier Type: NIH

Identifier Source: org_study_id

View Link