Find Traumatic Brain Injury Clinical Trials Near You
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
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
United Kingdom
Nottingham University Hosptials Trust
RECRUITING
Nottingham
Contact Information
Primary
Irene L Morgan-Brown, MSc, PGCert, BSc
lqxim2@nottingham.ac.uk
+44115 823 1924
Time Frame
Start Date:2025-10-21
Estimated Completion Date:2026-12
Participants
Target number of participants:180
Treatments
Part 1
Part 1 - Early Sleep Study - Cohort Study 'Part 1' will consist of a cohort study, in which participants are recruited from Nottingham University Hospitals Trust, within 12 weeks of sustaining their injury. The purpose of this study will be to understand the relationship between early sleep disturbance and recovery in TBI, including understanding the impact on functional recovery and mental health at 3- and 6-months post-injury.~A combination of subjective data (e.g. sleep diaries and questionnaires) and objective data (actigraphy to measure sleep disturbance via the GENEActiv wrist-worn device) will be used to measure recovery from TBI and sleep disturbance.
Part 2
Part 2 - Chronic Sleep Study - Cross-sectional 'Part 2' will consist of a cross-sectional study, in which participants are recruited from Nottingham University Hospitals Trust rehabilitation teams, at over 12 months after sustaining their TBI. The purpose of this study will be to understand the relationship between chronic sleep disturbance and recovery in TBI, including functional recovery and mental health. Within this study, we will also consider how these factors may impact on engagement with rehabilitation, as rated by a clinician. A combination of subjective data (e.g. sleep diaries and questionnaires) and objective data (actigraphy to measure sleep disturbance via the GENEActiv wrist-worn device) will be used to measure recovery from TBI and sleep disturbance.
Part 3
Part 3 - Interviews 'Part 3' will consist of semi-structured interviews with a sub-sample of participants from Parts 1 and 2. The purpose of this study will be to understand and explore the human experience of sleep disturbance and recovery in TBI.