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

NCT07120373 | Recruiting

• 2 other identifiers: 25028357334
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Sleep disturbance; Head injury; Traumatic brain injury; Sleep; Actigraphy; TBI

Outcome Measures

Primary Outcomes (2)

• Functional outcome

  Standardised and validated questionnaire: Extended Glasgow Outcome Score (GOSE)

  Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1 - 28

• Functional outcome

  Standardised and validated questionnaire: Quality of Life after Brain injury (QOLIBRI)

  Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1-28

Secondary Outcomes (5)

• Mental health outcome

  Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28

• Mental health outcome

  Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28

• Mental health outcome

  Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28

• Rehabilitation engagement outcome

  For Part 2: At any point between Day 1-28

• Subjective sleep disturbance outcome

  Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28

Other Outcomes (4)

• Exposure of interest

  For Part 1: Within 12 weeks of injury, for a 2 week period For Part 2: At over 12 months of injury, for a 2 week period

• Exposure of interest

  For Part 1: Within 12 weeks of injury, for a 2 week period For Part 2: At over 12 months of injury, for a 2 week period

• Exposure of interest

  For Part 1: Within 12 weeks of injury, for a 2 week period For Part 2: At over 12 months of injury, for a 2 week period

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People with traumatic brain injury, recruited from the following locations: Nottingham University Hospitals Trust, to include: * Emergency Department (Queens Medical Centre) * Neurosciences and Major Trauma wards (Queens Medical Centre) * Linden Lodge Inpatient Neuro Rehab / National Rehabilitation Centre (City Hospital and Stanford Hall) * Nottingham TBI Community Rehabilitation Team (City Hospital) * Nottingham Neuro Rehabilitation Outpatient team (City Hospital)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham University Hosptials Trust

Nottingham, Nottinghamshire, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Parasomnias; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Sleep Wake Disorders; Mental Disorders

Study Officials

• Professor Holly Blake

  University of Nottingham

  STUDY CHAIR

• Professor Andrew Bagshaw

  University of Birmingham

  STUDY DIRECTOR

• Dr Karen Mullinger

  University of Nottingham

  STUDY DIRECTOR

Central Study Contacts

Irene L Morgan-Brown, MSc, PGCert, BSc

CONTACT

+44115 823 1924; lqxim2@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 13, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

GB (1)