The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

Stroke Clinical Trial

— SLEEPR  

Official title:

The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012605
• Other study ID #: R01NR018979
• Status: Recruiting
• Start date: March 25, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2023
• Source: State University of New York - Upstate Medical University
• Contact: Karen J Klingman, PhD
• Phone: 315-464-4276
• Email: klingmak[@]upstate.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Observation
Observe physical function and sleep disorder symptoms following stroke

Locations

Country	Name	City	State
United States	Good Shepherd Rehabilitation Network	Allentown	Pennsylvania
United States	KU Medical Center, The University of Kansas	Kansas City	Kansas
United States	Institute for Human Performance - Upstate Rehabilitation at IHP	Syracuse	New York
United States	Upstate Community Hospital	Syracuse	New York
United States	Upstate University Hospital	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gait speed	Objective measure of gait speed from 10 meter walk test	15 days post-stroke
Secondary	Gait speed	Objective measure of gait speed from 10 meter walk test	60 days post-stroke
Secondary	Gait speed	Objective measure of gait speed from 10 meter walk test	90 days post-stroke
Secondary	Activity level	Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.	15 days post-stroke
Secondary	Activity level	Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.	60 days post-stroke
Secondary	Activity level	Objective measure of activity according to leg-worn activity monitor to be analyzed according to manufacturer's algorithm.	90 days post-stroke
Secondary	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
Secondary	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
Secondary	GG code for Mobility and Self Care Sections	Self care and functional mobility codes extracted from participants' medical records	15 days post-stroke
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sleep diary	Tabulation of participant's sleep habits from a written diary, over a one week timeframe.	60 days post-stroke
Secondary	Sleep diary	Tabulation of participant's sleep habits from a written diary, over a one week timeframe.	90 days post-stroke
Secondary	Oxygen desaturation index	Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight	90 days post-stroke
Secondary	Oxygen desaturation index	Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight	60 days post-stroke
Secondary	Oxygen desaturation index	Oxygen desaturations per minute index, as determined from a pulse oximeter worn overnight	15 days post-stroke
Secondary	Wrist actigraphy data	Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm	15 days post-stroke
Secondary	Wrist actigraphy data	Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm	60 days post-stroke
Secondary	Wrist actigraphy data	Data measured from a wrist-worn actigraph, to be analyzed according to manufacturer's algorithm	90 days post-stroke