Not yet recruitingOBSERVATIONAL

Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury

This research is investigating the link between sleep problems and mental health issues after a brain injury, such as a stroke. Many people experience difficulties with sleep and their mood or thinking after such an injury. We're observing whether poor sleep quality is connected to worse mental health. We'll also track how sleep and mental well-being change over the first year after the injury, checking in about every three months. This helps us understand if and how these two important aspects of recovery are related, aiming to provide better support in the future.

At a glance

Status

Not yet recruiting

Sponsor

University of Oxford

Enrolment target

150

Start

01 Oct 2025

Estimated completion

30 Nov 2027

Acquired Brain Injury (Including Stroke)

What is this study about?

When someone has a brain injury, such as a stroke or a severe knock to the head, it can affect many parts of their life. Two common problems that people experience are difficulties with sleep and changes in their mental well-being, like feeling low, anxious, or having trouble thinking clearly. This study aims to understand if there's a connection between these two things.

We want to find out if people who experience poor sleep after a brain injury also tend to have more difficulties with their mental health. We believe that there might be a link, where sleep problems could make mental health challenges worse, or slow down recovery. By looking at this relationship, we hope to learn more about how to best support people after a brain injury.

The study will follow people for up to a year after their brain injury. This means we'll check in with them at different times to see how their sleep and mental health change as they recover. This will give us a clearer picture of what happens over time and help us spot any patterns between sleep and mental well-being.

Key takeaways

This study explores the link between sleep and mental health after a brain injury.
It follows participants for up to one year to see how things change over time.
No new treatments or medicines are involved; it's about observation and gathering information.
You'll use questionnaires and wear small devices to monitor your sleep.
The findings could help improve future care for people with brain injuries.
You can stop participating at any point without affecting your medical care.

Who may be eligible?

You might be able to join this study if you are 18 years old or older and have had a brain injury, such as a stroke or a traumatic brain injury, within the last 12 months. It's important that your brain injury wasn't caused by something else, like a specific illness.

We're looking for people who haven't had a brain injury before this one and don't have other serious brain conditions like Parkinson's or Alzheimer's disease, as these could affect the study's results. You also need to have a stable and safe place to sleep.

To take part, you'll need to be willing to give your agreement to be part of the study. Also, if we have any worries about your mental health during the study, we would need your permission to get in touch with your GP or care team.

Quick self-check

Are you 18 years old or older?
Have you had a stroke or traumatic brain injury within the last 12 months?
Was this your first brain injury?
Do you have a stable and safe place to sleep?
Are you happy for the study team to contact your GP if they have concerns about your mental health?
Are you willing to complete questionnaires and use sleep monitoring devices?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you won't be given any new medicines or treatments. Instead, we'll be observing and collecting information about your sleep and mental well-being. This will involve filling out questionnaires about your sleep and how you're feeling emotionally.

We'll also ask you to use some special equipment to measure your sleep in detail. This includes wearing a small monitor on your wrist, using a portable sensor that measures your brain activity, and placing a thin mat under your mattress to track your sleep patterns. You'll do these assessments when you first join the study, and then approximately every three months for up to a year after your injury. There are also two optional parts of the study: one where you could keep a sleep mat on your bed for a whole year, and another that looks at how sleep might affect your movement skills.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather could help us understand sleep and mental health after brain injury better, leading to improved support for others in the future. The main 'risk' is the time commitment required for the assessments. Some questions about your mental health might also bring up difficult feelings, but you can choose to skip any questions you don't wish to answer. You are completely free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What kind of brain injury is this study looking at?

It's looking at acquired brain injuries, which include strokes (where blood supply to the brain is interrupted) and traumatic brain injuries (like a concussion or head injury).

Will I have to take any new medication?

No, this study doesn't involve any new medication. It's an observational study, meaning we'll just be gathering information about you.

How often will I need to do assessments?

You'll fill out questionnaires and use sleep monitoring devices when you start, and then about every three months for up to a year after your injury.

What if I feel uncomfortable answering some questions?

You can skip any questions you don't want to answer. Your comfort is important.

Will my family doctor (GP) be informed if I join?

We would only contact your GP or care team if we had concerns about your mental health, and we would ask for your permission first.

How to find out more

Melanie Fleming, PhD

melanie.fleming@ndcn.ox.ac.uk 00 44 1865 611 461 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.