The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation (SLEEPR)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Sleep Wake Disorders; Rehabilitation; Recovery of Function
• Intervention / Treatment: Other: Observation

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Karen J Klingman, PhD; Phone Number: 315-464-4276; Email: klingmak@upstate.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 39322
      • Recruiting
      • Emory University
      • Contact: George D Fulk, PhD PT; Phone Number: 404-727-9807
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • KU Medical Center, The University of Kansas
      • Contact: Sandra A Billinger, PhD; Phone Number: 913-588-5000; Email: sbillinger@kumc.edu
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Upstate University Hospital
      • Contact: Karen J Klingman, PhD; Phone Number: 315-464-4276; Email: klingmak@upstate.edu
    • Syracuse, New York, United States, 13210
      • Active, not recruiting
      • Institute for Human Performance - Upstate Rehabilitation at IHP
    • Syracuse, New York, United States, 13215
      • Suspended
      • Upstate Community Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 17193
      • Terminated
      • Good Shepherd Rehabilitation Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Observe physical function and sleep disorder symptoms following stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of disability according to the modified Rankin scale	the modified Rankin scale is used to measure degree of disability in patients who have had a stroke; scores range from 0-5, with higher numbers indicating the most disability	15 days post-stroke
Degree of disability according to the modified Rankin scale	the modified Rankin scale is used to measure degree of disability in patients who have had a stroke; scores range from 0-5, with higher numbers indicating the most disability	60 days post-stroke
Degree of disability according to the modified Rankin scale	the modified Rankin scale is used to measure degree of disability in patients who have had a stroke; scores range from 0-5, with higher numbers indicating the most disability	90 days post-stroke
Balance ability according to the Berg balance scale	The Berg balance scale is an observational measure of balance ability according to performance on 14 tasks; scores range from 0-56, with higher scores indicating better balance	15 days post-stroke
Balance ability according to the Berg balance scale	The Berg balance scale is an observational measure of balance ability according to performance on 14 tasks; scores range from 0-56, with higher scores indicating better balance	60 days post-stroke
Balance ability according to the Berg balance scale	The Berg balance scale is an observational measure of balance ability according to performance on 14 tasks; scores range from 0-56, with higher scores indicating better balance	90 days post-stroke
Gait speed	Objective measure of gait speed from 10 meter walk test	15 days post-stroke
Gait speed	Objective measure of gait speed from 10 meter walk test	60 days post-stroke
Gait speed	Objective measure of gait speed from 10 meter walk test	90 days post-stroke
Activity level	Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.	15 days post-stroke
Activity level	Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.	60 days post-stroke
Activity level	Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.	90 days post-stroke
Types of community locations visited by study participants, as determined from global positioning sensor data	Objective measure of location of participant over a one week timeframe	60 days post-stroke
Types of community locations visited by study participants, as determined from global positioning sensor data	Objective measure of location of participant over a one week timeframe	90 days post-stroke
GG code for Mobility and Self Care Sections	Self care and functional mobility codes extracted from participants' medical records	15 days post-stroke
Cognitive ability according to the Montreal cognitive assessment	the Montreal cognitive assessment ratess participants' performance on several tasks as scored by a trained observer; scores range 0-30 with higher scores indicating better cognitive ability.	15 days post-stroke
Cognitive ability according to the Montreal cognitive assessment	the Montreal cognitive assessment ratess participants' performance on several tasks as scored by a trained observer; scores range 0-30 with higher scores indicating better cognitive ability.	60 days post-stroke
Cognitive ability according to the Montreal cognitive assessment	the Montreal cognitive assessment ratess participants' performance on several tasks as scored by a trained observer; scores range 0-30 with higher scores indicating better cognitive ability.	90 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)	This is a self-report scale measuring frequency of depressive symptoms; scores range from 0-27 with higher scores indicating more severe depression	15 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)	This is a self-report scale measuring frequency of depressive symptoms; scores range from 0-27 with higher scores indicating more severe depression	60 days post-stroke
Depression severity as measured by the patient health questionnaire (9-item version)	This is a self-report scale measuring frequency of depressive symptoms; scores range from 0-27 with higher scores indicating more severe depression	90 days post-stroke
Sleep diary	Tabulation of participant's sleep habits from a written diary, over a one week timeframe.	60 days post-stroke
Sleep diary	Tabulation of participant's sleep habits from a written diary, over a one week timeframe.	90 days post-stroke
Oxygen desaturation index	Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight	90 days post-stroke
Oxygen desaturation index	Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight	60 days post-stroke
Oxygen desaturation index	Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight	15 days post-stroke
Wrist actigraphy data	Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm	15 days post-stroke
Wrist actigraphy data	Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm	60 days post-stroke
Wrist actigraphy data	Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm	90 days post-stroke
Daily activities as recorded by study participants (trip log)	tabulation of trip log - record of when they leave the house and where they are going.	60-days post-stroke
Daily activities as recorded by study participants (trip log)	tabulation of trip log - record of when they leave the house and where they are going.	90-days post-stroke

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Karen J Klingman, PhD, SUNY Upstate Medical University, College of Nursing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: patient reported outcome measures; actigraphy; Longitudinal study; spatial analysis; wearable electronic devices
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Sleep Wake Disorders
• Other Study ID Numbers: R01NR018979 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final research data along with meta-data and descriptors will be shared to the maximum extent possible while protecting patient privacy. Data will be for individual subjects. No aggregate data will be provided apart from what is published in the literature. Data will be formatted for SPSS and/or as csv files.
• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No