Sleep problems and recovery after a traumatic brain injury
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
Run by University of Nottingham · NCT07120373 · Data updated 2026-11-12
This project will try to see if sleep problems measured after a traumatic brain injury predict later mental health and how well adults recover their day-to-day activities.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT07120373 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with a medically diagnosed TBI who present to the emergency department within 24 hours, can consent, and are willing/able to wear an activity tracker at home are the ideal candidates.
✕Probably not a fit
People with pre-existing sleep disorders, other diagnosed neurological conditions, night-shift workers, or those outside the 18–60 age range are unlikely to benefit from the findings or be eligible for the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort study enrolling adults with a medically diagnosed traumatic brain injury who present to the emergency department within 24 hours of injury. Participants will wear an activity tracker (actigraphy) to collect longitudinal sleep and movement data in the weeks following injury, and researchers will collect mental health and functional outcome measures at 3 and 6 months. The study excludes people with pre-existing sleep disorders, other major neurological conditions, or night-shift work to focus on new sleep disturbance after injury. A literature summary is also planned to place the new findings in context of prior work on sleep and TBI recovery.
Why it matters
Potential benefit: If successful, the work could help identify people at higher risk of poor mental health or delayed functional recovery after TBI so clinicians can target follow-up and sleep-related interventions earlier.
How similar studies have gone: Previous observational studies have linked post-TBI sleep problems to worse outcomes, but few have used early, longitudinal actigraphy starting within days of injury, so this approach is partly building on prior work and partly novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Nottingham University Hosptials Trust
Nottingham, Nottinghamshire, United Kingdom Recruiting
Study contacts
- Study coordinator: Irene L Morgan-Brown, MSc, PGCert, BSc
- Email: lqxim2@nottingham.ac.uk
- Phone: +44115 823 1924
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.