Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury

NCT07215195 | Not Yet Recruiting

• 1 other identifier: PID 18842
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The two most common causes of brain injury are stroke and trauma. Both sleep and mental health problems are common after brain injury; we will investigate whether there is a relationship between poor sleep quality and worse mental health in this group. We will also follow patients up, at approximately three-monthly intervals until one year after injury, to see how sleep and mental health symptoms change over time and with recovery. We will assess sleep in detail using questionnaires, a sleep monitor worn on the wrist, a portable brain activity sensor, and a sleep mat. We will assess mental health (neuropsychiatric) symptoms using questionnaires. Participants will be asked to complete these assessments at baseline and at approximately 3-monthly intervals until they reach 12 months post-injury. This data will allow us to explore the types of sleep disruption seen after brain injury and examine the association between sleep and mental health symptoms.

Conditions

Acquired Brain Injury (Including Stroke)

Keywords

stroke; traumatic brain injury; neuropsychiatric disorder; movement; sleep; brain injury

Outcome Measures

Primary Outcomes (2)

• Neuropsychiatric (mental health) symptoms at baseline

  Assessed using the Diagnostic and Statistical Manual version 5 (DSM-5) Cross-Cutting Measure questionnaire level 1 total score. Range 0-92, higher scores indicate worse neuropsychiatric symptoms.

  Baseline (first assessment, obtained within 12 months of acquired brain injury)

• Self reported sleep quality at baseline

  Assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Range 0-21, higher scores indicate worse sleep quality.

  Baseline (first assessment, obtained within 12 months of acquired brain injury)

Secondary Outcomes (13)

• Neuropsychiatric (mental health) symptoms

  Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)

• Sleep Fragmentation Index

  Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).

• Time in each stage of sleep

  Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).

• Slow wave sleep (SWS) amplitude

  Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).

• Sleep spindle power

  Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).

Other Outcomes (11)

• Sleep continuity assessed with a mattress sensor

  Continuous from baseline until 12 months after acquired brain injury

• Motor impairment

  Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)

• Upper limb ability

  Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)

Study Arms (1)

Adults with acquired brain injury

We will follow adults with either stroke or traumatic brain injury for one year post-injury to examine the associations between sleep, mental health and motor recovery.

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

Adult patients, age 18 years or over (no upper age limit) within one year of acquired brain injury (stroke, haemorrhage, trauma)

You may qualify if:

• Willing and able to give informed consent for participation in the study.
• Aged 18 years or above.
• At least one week, but less than 12 months post-injury
• Clinical diagnosis of acquired brain injury (stroke, haemorrhage or traumatic).
• Participants with Traumatic Brain Injury will have a Mild (probable) or Moderate-severe (definite) brain injury according to the Mayo classification
• Participants must be willing to consent to us contacting their general practitioner (GP) or direct care team if we have concerns about their mental health

You may not qualify if:

• Brain injury not caused by trauma, haemorrhage or stroke
• Previous brain injury.
• Other relevant neurological conditions which could affect outcome measures (e.g., Parkinson's or Alzheimer's disease)
• No stable and suitable place to sleep

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Wellcome Centre for Integrative Neuroimaging (WIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford OX3 9DU

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Melanie Fleming, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Fleming, PhD

CONTACT

00 44 1865 611 461; melanie.fleming@ndcn.ox.ac.uk

Brent Elliott, MBBBS MSc

CONTACT

00 44 7967 418523; brent.elliott@keble.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: October 1, 2025
• First Posted: October 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available following publication or public release of the main findings, for approximately 2 years.
• Access Criteria: Anonymous data will be available upon reasonable request to the Principal Investigator, using file transfer (e.g. Microsoft OneDrive).

Locations

GB (1)