NCT07215195 Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury
| NCT ID | NCT07215195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Acquired Brain Injury (Including Stroke) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-10-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Melanie Fleming, PhD
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT07215195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acquired Brain Injury (Including Stroke). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07215195 currently recruiting?
Yes, NCT07215195 is actively recruiting participants. Contact the research team at melanie.fleming@ndcn.ox.ac.uk for enrollment information.
Where is the NCT07215195 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT07215195 clinical trial?
NCT07215195 is sponsored by University of Oxford. The principal investigator is Melanie Fleming, PhD at University of Oxford. The trial plans to enroll 150 participants.
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