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NCT07120373

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

Sponsor: University of Nottingham

View on ClinicalTrials.gov

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.

Official title: An Exploration of the Relationship Between Sleep Disturbance, Mental Health, and Functional Outcomes in Mild, Moderate and Severe Traumatic Brain Injury (TBI): A Mixed Methods Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2025-09-01

Completion Date

2026-09-01

Last Updated

2025-08-13

Healthy Volunteers

Conditions

Traumatic Brain Injury

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, 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 - For clinicians Inclusion criteria: * A registered healthcare professional working at Nottingham University Hospitals Trust * Clinical experience of delivering rehabilitation services to participants with TBI that have been recruited to the study Exclusion criteria: * Not contactable via telephone, letter or email * Unable to understand the study requirements or give informed consent Part 3 • Inclusion/Exclusion criteria as stated above. 50% of participants will be recruited from Part 1, and 50% of participants will be recruited from Part 2 for both studies.

Locations (1)

Nottingham University Hosptials Trust

Nottingham, Nottinghamshire, United Kingdom