Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury (NCT07215195) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury
United Kingdom150 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neuropsychiatric (mental health) symptoms at baseline
Timeframe: Baseline (first assessment, obtained within 12 months of acquired brain injury)
2
Self reported sleep quality at baseline
Timeframe: Baseline (first assessment, obtained within 12 months of acquired brain injury)