Sleep and Motor Learning in Stroke

NCT05746260 | Recruiting

• 1 other identifier: PID 16062
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore whether sleep disruption in the sub-acute phase of stroke explains variation in clinical motor outcomes, and whether this relationship is mediated by variation in behavioural measures of overnight consolidation.

Conditions

Stroke

Keywords

Rehabilitation; Motor Consolidation

Outcome Measures

Primary Outcomes (4)

• Sleep fragmentation at 1-month

  Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).

  1 month post-stroke

• Symptoms of insomnia at 1-month

  Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)

  1 month post-stroke

• Upper limb ability

  Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)

  6 month post-stroke

• Behavioural motor consolidation

  Assessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest

  1 month post-stroke

Secondary Outcomes (6)

• Whole body motor impairment

  6 months post-stroke

• Hand dexterity

  6 months post-stroke

• Mobility

  6 months post-stroke

• Estimated Total Sleep Time

  1 and 6 months post-stroke

• Wake After Sleep Onset

  1 and 6 months post-stroke

Other Outcomes (7)

• Electroencephalography (EEG) Sleep Measures

  1 month post-stroke

• Mood (Depression)

  1 and 6 months post-stroke

• Risk of Obstructive Sleep Apnoea

  1 month post-stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with stroke affecting the upper limb

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice
• Aged 18 years or above
• Within 1 month of onset of stroke affecting the upper limb as confirmed by clinical diagnosis

You may not qualify if:

• Other neurological condition affecting movement (such as Parkinson's disease, Multiple Sclerosis)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Wellcome Centre for Integrative Neuroimaging (WIN)

Oxford, OX3 9DU, United Kingdom

RECRUITING

Related Publications (1)

• Weightman M, Robinson B, Mitchell MP, Garratt E, Teal R, Rudgewick-Brown A, Demeyere N, Fleming MK, Johansen-Berg H. Sleep and motor learning in stroke (SMiLES): a longitudinal study investigating sleep-dependent consolidation of motor sequence learning in the context of recovery after stroke. BMJ Open. 2024 Feb 13;14(2):e077442. doi: 10.1136/bmjopen-2023-077442.

  PMID: 38355178 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Heidi Johansen-Berg, Professor

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie K Fleming, Dr

CONTACT

01865 611 461; melanie.fleming@ndcn.ox.ac.uk

Barbara Robinson

CONTACT

sleep-win@ndcn.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 27, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of results
• Access Criteria: Available upon reasonable request

Locations

GB (1)