Sleep and mood after acquired brain injury: see if poor sleep links with neuropsychiatric symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort study of adults within 12 months of an acquired brain injury, including stroke or traumatic brain injury. Researchers will collect detailed sleep data using questionnaires, wrist actigraphy, a portable brain activity sensor, and a sleep mat, alongside neuropsychiatric symptom questionnaires. Participants are followed at roughly three-month intervals for up to one year to explore how sleep quality relates to mental health and how both change during recovery. Secondary analyses will examine associations between objective sleep measures and neuropsychiatric symptoms, and two optional sub-studies will assess long-term sleep-mat metrics and links between sleep and motor function changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

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

Study contacts

• Principal investigator: Melanie Fleming, PhD — University of Oxford
• Study coordinator: Melanie Fleming, PhD
• Email: melanie.fleming@ndcn.ox.ac.uk
• Phone: 00 44 1865 611 461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.