The SLEEPR Study: Sleep Effects on Post-stroke Rehabilitation

The SLEEPR Study is looking into how sleep problems, other than obstructive sleep apnea (OSA), affect recovery after a stroke. Researchers want to understand how common these sleep issues are and how they impact your ability to do daily activities, move around, and participate in life after a stroke. This study will simply observe your physical function and sleep disorder symptoms after a stroke. To join, you must be at least 18 years old, have had a stroke confirmed by a doctor, and be admitted to an inpatient rehabilitation facility. The study will measure your independence in daily activities at 15, 60, and 90 days after your stroke. The current status of this study is unclear.

Study design
This is an observational study involving about 200 participants. It aims to understand the relationship between sleep disorders and stroke recovery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days after their stroke to assess functional independence.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05012605

The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation

UNKNOWN
Not specifiedAges 18+Observational
State University of New York - Upstate Medical University
~200 participants
Updated 2024-05-22 on ClinicalTrials.gov
What's tested:Observation

At a glance

Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional independence with activities of daily living as measured by the Barthel index
Measured over 15 days post-stroke
+16 more outcomes measured
Stroke
Sleep Wake Disorders
Rehabilitation
Recovery of Function

NCT05012605

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • KU Medical Center, The University of Kansas

    Kansas City, Kansasstudy coordinator listed

    Recruiting

  • Upstate University Hospital

    Syracuse, New Yorkstudy coordinator listed

    Recruiting

  • Good Shepherd Rehabilitation Network

    Allentown, Pennsylvaniano site contact published

    Terminated

  • Institute for Human Performance - Upstate Rehabilitation at IHP

    Syracuse, New Yorkno site contact published

    Active, not recruiting

  • Upstate Community Hospital

    Syracuse, New Yorkno site contact published

    Suspended

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • Functional independence with activities of daily living as measured by the Barthel index15 days post-stroke

    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

  • Functional independence with activities of daily living as measured by the Barthel index60 days post-stroke

    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

  • Functional independence with activities of daily living as measured by the Barthel index90 days post-stroke

    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

  • Level of disability according to the stroke impact scale60 days post-stroke

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

  • Level of disability according to the stroke impact scale90 days post-stroke

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

  • Daytime sleepiness according to the Epworth Sleepiness Scale15 days post-stroke

    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

  • Daytime sleepiness according to the Epworth Sleepiness Scale60 days post-stroke

    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

  • Daytime sleepiness according to the Epworth Sleepiness Scale90 days post-stroke

    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

  • Insomnia severity as determined from the insomnia severity index15 days post-stroke

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

  • Insomnia severity as determined from the insomnia severity index60 days post-stroke

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

  • Insomnia severity as determined from the insomnia severity index90 days post-stroke

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

  • Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire15 days post-stroke

    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.

  • Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire60 days post-stroke

    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.

  • Likely presence of restless legs syndrome as measured by the Cambridge Hopkins restless legs questionnaire90 days post-stroke

    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.

  • Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version15days post-stroke

    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.

  • Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version60days post-stroke

    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.

  • Cumulative morbidity of sleep disorders, as determined from the sleep disorders checklist, 25 item version90 days post-stroke

    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.