The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

NCT05012605 | Recruiting

• 1 other identifier: R01NR018979
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Stroke; Sleep Wake Disorders; Rehabilitation; Recovery of Function

Keywords

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

Outcome Measures

Primary Outcomes (17)

• Functional independence with activities of daily living as measured by the Barthel index

  The Barthel index is a measure of functional independence with activities of daily living; the score range is 0-100 with higher numbers indicating more independence

  15 days post-stroke

• Functional independence with activities of daily living as measured by the Barthel index

  The Barthel index is a measure of functional independence with activities of daily living; the score range is 0-100 with higher numbers indicating more independence

  60 days post-stroke

• Functional independence with activities of daily living as measured by the Barthel index

  The Barthel index is a measure of functional independence with activities of daily living; the score ranges 0-100 with higher numbers indicating more independence

  90 days post-stroke

• Level of disability according to the stroke impact scale

  The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function

  60 days post-stroke

• Level of disability according to the stroke impact scale

  The stroke impact scale is a self-report measure of disability; scores range from 0-100 with higher numbers indicating better function

  90 days post-stroke

• Daytime sleepiness according to the Epworth Sleepiness Scale

  Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness

  15 days post-stroke

• Daytime sleepiness according to the Epworth Sleepiness Scale

  Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness

  60 days post-stroke

• Daytime sleepiness according to the Epworth Sleepiness Scale

  Epworth sleepiness scale is a self report measure describing likelihood of falling asleep during different circumstances; scores range from 0-24, with higher numbers indicating more sleepiness

  90 days post-stroke

• Insomnia severity as determined from the insomnia severity index

  The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia

  15 days post-stroke

• Insomnia severity as determined from the insomnia severity index

  The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia

  60 days post-stroke

• Insomnia severity as determined from the insomnia severity index

  The insomnia severity index is a self report measure of insomnia severity; scores range from 0-28, with higher numbers indicating more severe insomnia

  90 days post-stroke

• Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire

  The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.

  15 days post-stroke

• Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire

  The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.

  60 days post-stroke

• Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire

  The Cambridge Hopkins restless legs questionnaire is a self report measure of presence and frequency of symptoms of restless legs syndrome; responses are scored according to an algorithm that provides yes/no for likely presence of restless legs syndrome.

  90 days post-stroke

• Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version

  The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.

  15days post-stroke

• Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version

  The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.

  60days post-stroke

• Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version

  The sleep disorders checklist, 25 item version, is a self report questionnaire of frequency of occurrence of 25 sleep disorder symptoms; scores range from 0-100, with higher numbers indicating worse overall morbidity of sleep disorders.

  90 days post-stroke

Secondary Outcomes (31)

• Degree of disability according to the modified Rankin scale

  15 days post-stroke

• Degree of disability according to the modified Rankin scale

  60 days post-stroke

• Degree of disability according to the modified Rankin scale

  90 days post-stroke

• Balance ability according to the Berg balance scale

  15 days post-stroke

• Balance ability according to the Berg balance scale

  60 days post-stroke

Study Arms (1)

SLEEPR cohort

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

Other: Observation

Interventions

Observation OTHER

Observe physical function and sleep disorder symptoms following stroke

SLEEPR cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults recovering from stroke within the first 90 days following stroke who did not have a diagnosis of obstructive sleep apnea (OSA) prior to stroke or who do not have oxygen desaturation index (ODI) of 15 or higher during inpatient rehabilitation (\~15 days post-stroke).

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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (6)

Emory University

Atlanta, Georgia, 39322, United States

RECRUITING

KU Medical Center, The University of Kansas

Kansas City, Kansas, 66160, United States

RECRUITING

Institute for Human Performance - Upstate Rehabilitation at IHP

Syracuse, New York, 13210, United States

ACTIVE NOT RECRUITING

Upstate University Hospital

Syracuse, New York, 13210, United States

RECRUITING

Upstate Community Hospital

Syracuse, New York, 13215, United States

SUSPENDED

Good Shepherd Rehabilitation Network

Allentown, Pennsylvania, 17193, United States

TERMINATED

Related Publications (1)

• 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.

  PMID: 35948301 DERIVED

MeSH Terms

Conditions

Stroke; Sleep Wake Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Karen J Klingman, PhD

  SUNY Upstate Medical University, College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen J Klingman, PhD

CONTACT

315-464-4276; klingmak@upstate.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 19, 2021
• Study Start: March 25, 2021
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anticipated availability of the dataset will be announced during the final year of the project, with notification of how to apply for access to the data. Data will be deposited into the institutional repository as soon as possible, after key manuscripts have been accepted for publication. Should manuscripts be delayed due to unforeseen circumstances, data will be available through the repository within a year of project closure. Data will remain available by request from the PI during time of employment at SUNY Upstate, after which time the SUNY Upstate library will manage and grant access according to guidelines set forth by the IRB.
• Access Criteria: An online data request form will be available so that others can indicate their interest in the data through a publicly available website. A data sharing agreement will be signed by all parties. Because detailed pattern of life information may contain information that may allow subject identity to be recovered, we intend to provide two levels of data sharing with three classes of data. 1. Controlled share: data (to include pattern-of-life data) that contains information for which identity could be recovered if analyzed with malicious intent. These data will only be released to vetted researchers under conditions that provide assurance of protected privacy. 2. Public share: a subset of the variables that are not expected to provide privacy risk; and Geo-summarized or modified data - consistent with state-of-the-art methodologies for differential privacy, the collected participation (geolocation) data will be made available after the data has been modified to preserve privacy.

Locations

US (6)