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

ConditionTraumatic Brain Injury

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorUniversity of Nottingham

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants

are grouped into 3 trial groups

Group A: Part 1

Group B: Part 2

Group C: Part 3

Trial outcomes

Primary outcomes

Functional outcome

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

Time frame

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)

Time frame

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

Secondary outcomes

Mental health outcome

Standardised and validated questionnaire: Patient Health Questionnaire (PHQ-9)

Time frame

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

Mental health outcome

Standardised and validated questionnaire: General Anxiety Disorder-7 (GAD-7)

Time frame

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

Mental health outcome

Standardised and validated questionnaire: Post Traumatic Stress Disorder Checklist 5 (PCL-5)

Time frame

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

Rehabilitation engagement outcome

Standardised and validated questionnaire: Hopkins Rehabilitation Engagement Rating Scale (HRERS). Completed by clinicians working with participants recruited into the study.

Time frame

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

Other outcomes

Exposure of interest

Actigraphy of sleep data from the GENEActiv device: • Total Sleep Duration (mm:hh)

Time frame

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

Actigraphy of sleep data from the GENEActiv device: • WASO (Wake After Sleep Onset) (mm:hh)

Time frame

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

Actigraphy of sleep data from the GENEActiv device, including: • Sleep Efficiency (%)

Time frame

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

Actigraphy of sleep data from the GENEActiv device: • Sleep Onset Latency (hh:mm)

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov

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