Actively Recruiting

Age: 18Years - 60Years
All Genders
NCT07120373

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

Led by University of Nottingham · Updated on 2026-05-06

180

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

Sponsors

U

University of Nottingham

Lead Sponsor

N

Nottingham University Hospitals NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-60 years
  • Medically diagnosed traumatic brain injury of any severity
  • Glasgow Coma Scale score documented on admission or in medical notes
  • Able to provide informed consent to participate
  • Able to wear an activity tracker for 2 weeks in usual home environment
  • For Part 1: Presenting to Emergency Department within 24 hours of head injury
  • For Part 2: Injury sustained more than 12 months ago
  • For clinicians in Part 2: Registered healthcare professional with experience delivering rehabilitation to TBI patients at Nottingham University Hospitals Trust
Not Eligible

You will not qualify if you...

  • Unable to understand study requirements or provide informed consent
  • Diagnosed neurological conditions such as stroke, brain tumor, epilepsy, motor neuron disease, Parkinson's disease, or spinal cord injury
  • No clear definition of TBI or unknown time since injury
  • Pre-existing sleep disorder
  • Working night shifts
  • Not contactable by telephone, letter, or email

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nottingham University Hosptials Trust

Nottingham, Nottinghamshire, United Kingdom

Actively Recruiting

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Research Team

I

Irene L Morgan-Brown, MSc, PGCert, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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