RecruitingNot Applicable

An Exploration of Sleep Disturbance and Outcomes in TBI (SLEEP-TBI)

United Kingdom180 participantsStarted 2025-10-21

Plain-language summary

This study aims to look at how sleep disturbance affects people who have had a traumatic brain injury. Sleep disturbance can include waking frequently in the night, difficulty falling asleep, excessive sleepiness or changes to usual sleep patterns. Investigators define traumatic brain injury as an injury caused by a forceful bump, blow, or jolt to the head or body, or from an object entering the brain. This results in a disturbance of normal brain function, that can be temporary. By understanding the relationship between sleep disturbance and traumatic brain injury, investigators will hopefully improve care and treatment for people with a traumatic brain injury. Investigators are looking to understand each participant's experience of sleep disturbance, as well as measuring sleep, using a device that monitors movement and sleep quality. Investigators are interested how sleep disturbance impacts things like day-to-day life and activities, such as work or leisure. Investigators are also interested in mental health, such as depression or anxiety.

Who can participate

Age range

18 Years – 60 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.

Part 1 Inclusion criteria: * Age 18-60 years * Patients presenting to the Emergency Department within 24 hours of head injury * Medically diagnosed TBI of any severity * Glasgow Coma Scale (GCS) score documented on admission * Able to provide informed consent to take part in the study * To be able to wear an activity tracker for a period of 2 weeks, in usual home environment within 12 weeks of injury Exclusion criteria: * Unable to understand the study requirements or give informed consent * Other diagnosed neurological condition such as, but not limited to, stroke, brain tumour, epilepsy, motor neuron disease, Parkinson's disease, or spinal cord injury * No definition of TBI or description of TBI severity, patient report only, or unknown time since injury * Pre-existing sleep disorder (self-reported or from clinical records) * Individuals that have working patterns that include night shifts * Not contactable via telephone, letter or email Part 2 Inclusion criteria: * Age 18-60 years * Medically diagnosed TBI of any severity * Glasgow Coma Scale (GCS) score documented in medical notes * Able to provide informed consent to take part in the study * TBI sustained \>12 months * Able to wear an activity tracker in usual home environment for a period of 2 weeks Exclusion criteria: * Unable to understand the study requirements or give informed consent * Other diagnosed neurological condition such as, but not limited to, stroke, brain tumour, epilepsy, motor neuron disease, …

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

Functional outcome

Timeframe: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1 - 28

Functional outcome

Timeframe: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1-28

Trial details

NCT IDNCT07120373

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Irene L Morgan-Brown, MSc, PGCert, BSc

+44115 823 1924 lqxim2@nottingham.ac.uk

View on ClinicalTrials.gov More Traumatic Brain Injury trials