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

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.

• Mental health outcome [Срок оценки: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
• Mental health outcome [Срок оценки: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
• Mental health outcome [Срок оценки: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]
• Rehabilitation engagement outcome [Срок оценки: For Part 2: At any point between Day 1-28]
• Subjective sleep disturbance outcome [Срок оценки: Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28]