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

Sponsor
University of Nottingham
Study ID
NCT07120373
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 13, 2025
Start date
Oct 21, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Functional outcome [ Time Frame: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1 - 28 ]

Central Contacts

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