An Exploration of Sleep Disturbance and Outcomes in TBI (SLEEP-TBI)
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
University of Nottingham
180 participants
Oct 21, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria15
- Part 1
- 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
- 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
- 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 Criteria17
- 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
- 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
- Not contactable via telephone, letter or email
- Unable to understand the study requirements or give informed consent
- Part 3
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07120373