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

Launched by UNIVERSITY OF NOTTINGHAM · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial, called SLEEP-TBI, is studying how sleep problems affect people who have had a traumatic brain injury (TBI). A TBI happens when a strong hit or jolt to the head or body temporarily affects how the brain works. Sleep problems can include things like waking up often during the night, having trouble falling asleep, feeling very sleepy during the day, or changes in usual sleep habits. The goal of this study is to better understand how these sleep issues impact daily life, including work, hobbies, and mental health like feelings of depression or anxiety, so that care and treatment for people with TBI can be improved.

People aged 18 to 60 who have had a medically diagnosed TBI are welcome to join, whether the injury happened recently (within the past 12 weeks) or more than a year ago. To take part, participants need to be able to wear a small activity tracker at home for two weeks, which will help measure their sleep and movement. Participants will also share their experiences with sleep problems and how these affect their daily activities. The study is currently not yet recruiting, and people with other neurological conditions or pre-existing sleep disorders, or those who work night shifts, may not be eligible. Overall, this study offers a chance to help researchers learn more about the connection between sleep and brain injury to improve support for those affected.

Gender

ALL

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.