NCT07120373 An Exploration of Sleep Disturbance and Outcomes in TBI (SLEEP-TBI)
| NCT ID | NCT07120373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2025-10-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Professor Holly Blake
STUDY CHAIR
University of Nottingham
Frequently Asked Questions
Who can join the NCT07120373 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07120373 currently recruiting?
Yes, NCT07120373 is actively recruiting participants. Contact the research team at lqxim2@nottingham.ac.uk for enrollment information.
Where is the NCT07120373 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT07120373 clinical trial?
NCT07120373 is sponsored by University of Nottingham. The principal investigator is Professor Holly Blake at University of Nottingham. The trial plans to enroll 180 participants.