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 range18 Years – 60 Years

SexALL

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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, …

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