An Exploration of Sleep Disturbance and Outcomes in TBI (SLEEP-TBI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploration of the Relationship Between Sleep Disturbance, Mental Health, and Functional Outcomes in Mild, Moderate and Severe Traumatic Brain Injury (TBI): A Mixed Methods Study
Overview
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.
Detailed description
The focus of the study will be to determine whether sleep data acquired longitudinally over the months following traumatic brain injury (TBI) predicts long-term mental health and functional outcomes, including return to normal activities, such as work. The overarching aim is to improve the care and treatment that people with TBI experience, by understanding the predictive value of sleep disturbances.
Overall research aim
The overall aim of this study is to understand the relationship between sleep disturbance and long-term mental health and functional recovery, as a step to improving the care, treatment and outcomes that people with TBI experience.
Primary Objective • To investigate the relationships between sleep disturbance, mental health outcomes and functional recovery in people with TBI.
Secondary Objectives
• To summarise what the literature indicates about how sleep disturbance impacts outcomes in recovery from TBI, including in the context of engagement with rehabilitation.
Part 1 - Cohort study
* To investigate the relationships between sleep disturbance and functional recovery at 3- and 6-months post-injury in people with TBI. * To investigate the relationships between sleep disturbance and mental health at 3- and 6-months post-injury in people with TBI. * To understand the impact of injury severity on mental health, and functional outcomes, in the context of sleep disturbance. * To understand the fundamental properties of sleep disturbance for people who have sustained a TBI in the acute stage.
Part 2 - Cross-sectional study
* To investigate the relationships between chronic sleep disturbance, mental health and functional outcomes at over 1-year post-TBI. * To understand how sleep disturbance and traumatic brain injury may impact on engagement with rehabilitation. * To understand the fundamental properties of sleep disturbance for people who have sustained a TBI in the chronic stage.
Part 3 - Interviews
* To understand the human experience of TBI recovery and sleep disturbance. * To explore people's perceptions of recovery and rehabilitation, in the context of TBI and sleep disturbance.
STUDY CONFIGURATION
This is a single-centre study taking place at Nottingham University Hospitals Trust (NUH). The configuration will be as follows:
Part 1
Cohort study with recruitment of those that meet the eligibility criteria from the Emergency Department and inpatient wards at NUH.
Part 2
Cross-sectional study design of those that meet the eligibility criteria recruited from Nottingham TBI community and outpatient rehabilitation teams at NUH.
Part 3
Semi-structured qualitative interviews using a sub-sample of participants from Part 1 and 2 studies.
DURATION OF THE STUDY AND PARTICIPANT INVOLVEMENT
Part 1 The recruitment process will begin once all approvals are in place, estimated to begin in September 2025 and end in February 2026. The follow-up time period will be 6 months for each participant, therefore, the estimated duration per participant will be 7 months. The total estimated study time is 12 months (completion in September 2026).
Participant involvement:
GENEActiv Device to be worn for a continuous 2 week period. Sleep diaries to be completed whilst participants are wearing the device, this will take approximately 5 minutes each day.
Questionnaires will take participants approximately 60 minutes to complete at the 3 and 6-month time points.
Part 2 The recruitment process is estimated to begin in March 2026, with a duration of 3 months. As data will be taken at a single time-point, the total duration of the study is estimated to be 4 months (completion in June 2026).
Participant involvement:
GENEActiv Device to be worn for a continuous 2 week period. Sleep diaries to be completed whilst participants are wearing the device, this will take approximately 5 minutes each day.
Questionnaires will take participants approximately 60 minutes to complete a single time point.
Part 3 Recruitment will take place by sampling from the 2 previous studies, with a planned start date of July 2026. Interviews will take place over 4-6 weeks, therefore the total study duration is estimated to be 6 weeks (completion in August 2026).
Participant involvement:
The interviews are estimated to take between 45-60minutes.
Recruitment
Participants will be recruited from one of the following departments at Nottingham University Hospitals Trust (NUH):
* The Emergency Department * Neurosciences * Major Trauma * the National Rehabilitation Centre/ Linden Lodge Inpatient Rehab * Nottingham TBI Team * Nottingham Neuro Outpatient Services
The initial approach will be from a member of the patient's usual care team (which may include the investigator or research nurses at NUH). Participants will either be approached whilst they remain an inpatient at the hospital or post-discharge by their usual care team, by reviewing admissions by database and contacting participants by telephone, letter or email to gain consent to participate and determine study eligibility.
A sampling strategy will be in place to recruit participants across TBI severity, and to ensure diversity of the sample, such as across age and sex.
The investigator or their nominee, e.g. from the research team or a member of the participant's usual care team, will inform the participant of all aspects pertaining to participation in the study.
Participants will be given a chance to take the study information home if needed for further consideration or family consultancy. Participants will be excluded from the study anytime if they are unwilling to participate or unable to give informed consent.
If needed, the usual hospital interpreter and translator services will be available to assist with discussion of the study, the participant information sheets, and consent forms, but the consent forms and information sheets will not be available in other languages.
Primary outcome measures
- Functional outcome [Time frame: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1 - 28]
- Functional outcome [Time frame: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1-28]
Secondary outcome measures (5)
- Mental health outcome [Time frame: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
- Mental health outcome [Time frame: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
- Mental health outcome [Time frame: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
- Rehabilitation engagement outcome [Time frame: For Part 2: At any point between Day 1-28]
- Subjective sleep disturbance outcome [Time frame: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Nottingham University Hosptials Trust — Nottingham
Identifiers
NCT: NCT07120373 · 25028 · 357334