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

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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

180 Participants
are grouped into 3 trial groups

Sponsors and collaborators

University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator