Actively Recruiting
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
Led by University of Nottingham · Updated on 2026-05-06
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Nottingham
Lead Sponsor
N
Nottingham University Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how sleep disturbances affect people who have experienced a traumatic brain injury (TBI), which can occur from a forceful bump or jolt to the head or body. The study aims to understand how sleep issues relate to mental health and recovery outcomes, including returning to normal daily activities like work. By exploring this connection, the hope is to improve care and treatment for individuals with TBI. The study includes three parts: Part 1 is a cohort study recruiting participants within 12 weeks of their injury, where they wear a wrist device called GENEActiv to monitor sleep and movement for two weeks and complete sleep diaries and questionnaires at 3 and 6 months post-injury. Part 2 is a cross-sectional study of people with chronic TBI (injury older than 12 months) who also wear the device for two weeks and complete questionnaires once. Part 3 involves interviews with a subset of participants from the first two parts to explore their experiences of sleep disturbance and recovery. Participants will wear the GENEActiv device continuously for two weeks and fill out daily sleep diaries, which take about five minutes each day. Questionnaires assessing mental health and functional recovery take about an hour to complete. Interviews last 45 to 60 minutes and may be conducted online, in person, or by phone. The study measures include sleep quality, mental health, functional outcomes, and rehabilitation engagement. The total participation time varies by study part, with individual follow-up lasting up to 7 months in Part 1. Data confidentiality and participant support are provided throughout the research.
CONDITIONS
Brief Title
An Exploration of Sleep Disturbance and Outcomes in TBI (SLEEP-TBI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years
- Medically diagnosed traumatic brain injury (TBI) of any severity
- Glasgow Coma Scale (GCS) score documented on admission or in medical notes
- Able to provide informed consent to take part in the study
- Able to wear an activity tracker for 2 weeks within usual home environment
- For Part 1: presenting to Emergency Department within 24 hours of injury
- For Part 2: TBI sustained more than 12 months ago
- For clinicians in Part 2: registered healthcare professional with experience delivering rehabilitation to TBI patients
You will not qualify if you...
- Unable to understand the study requirements or provide informed consent
- Other diagnosed neurological conditions such as stroke, brain tumour, epilepsy, motor neuron disease, Parkinson's disease, or spinal cord injury
- No formal definition or description of TBI severity, or unknown time since injury
- Pre-existing sleep disorder (self-reported or clinical records)
- Individuals with working patterns that include night shifts
- Not contactable via telephone, letter, or email
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 2 weeks
Participants wear a wrist-worn activity tracker (GENEActiv device) continuously for 2 weeks and complete daily sleep diaries to record sleep patterns. This monitoring occurs within 12 weeks of injury for Part 1 and at a single time point for Part 2 participants over 12 months post-injury.
Participants receive and return the device by post or in person; daily sleep diary completion (~5 minutes each morning)
Duration - At 3 and 6 months for Part 1; single time point for Part 2
Participants complete questionnaires assessing mental health and functional recovery. For Part 1, questionnaires are completed at 3 and 6 months post-injury. For Part 2, questionnaires are completed at a single time point more than 12 months post-injury. Clinicians working with Part 2 participants also complete brief questionnaires regarding rehabilitation engagement.
2 questionnaire sessions for Part 1; 1 questionnaire session for Part 2; options include telephone, online, or paper-based completion; clinician questionnaires approximately 2-3 minutes each
Duration - Additional 2 weeks at 6 months post-injury
A sample of participants may be asked to wear the activity tracker and complete sleep diaries for an additional 2-week period at 6 months post-injury to further assess sleep disturbance.
Participants receive and return the device by post or in person; daily sleep diary completion (~5 minutes each morning)
Duration - 4 to 6 weeks
Semi-structured interviews are conducted with a sub-sample of participants from Parts 1 and 2 to explore the human experience of sleep disturbance and recovery after TBI.
Interviews last 45 to 60 minutes and can be conducted online, in-person, or over the telephone
Trial Site Locations
Total: 1 location
1
Nottingham University Hosptials Trust
Nottingham, Nottinghamshire, United Kingdom
Actively Recruiting
Research Team
I
Irene L Morgan-Brown, MSc, PGCert, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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