💬In plain words
What the trial is, and whether it could suit you
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 disturba
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Part 1
Inclusion criteria:
* 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
Exclusion criteria:
* 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
Inclusion criteria:
* 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
Exclusion criteria:
* 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 - For clinicians
Inclusion criteria:
* A registered healthcare professional working at Nottingham University Hospitals Trust
* Clinical experience of delivering rehabilitation services to participants with TBI that have been recruited to the study
Exclusion criteria:
* Not contactable via telephone, letter or email
* Unable to understand the study requirements or give informed consent
Part 3
• Inclusion/Exclusion criteria as stated above. 50% of participants will be recruited from Part 1, and 50% of participants will be recruited from Part 2 for both studies.
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