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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Functional outcome
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
Part 1
Part 1 - Early Sleep Study - Cohort Study 'Part 1' will consist of a cohort study, in which participants are recruited from Nottingham University Hospitals Trust, within 12 weeks of sustaining their injury. The purpose of this study will be to understand the relationship between early sleep disturbance and recovery in TBI, including understanding the impact on functional recovery and mental health at 3- and 6-months post-injury.
A combination of subjective data (e.g. sleep diaries and questionnaires) and objective data (actigraphy to measure sleep disturbance via the GENEActiv wrist-worn device) will be used to measure recovery from TBI and sleep disturbance.
Part 2
Part 2 - Chronic Sleep Study - Cross-sectional 'Part 2' will consist of a cross-sectional study, in which participants are recruited from Nottingham University Hospitals Trust rehabilitation teams, at over 12 months after sustaining their TBI. The purpose of this study will be to understand the relationship between chronic sleep disturbance and recovery in TBI, including functional recovery and mental health. Within this study, we will also consider how these factors may impact on engagement with rehabilitation, as rated by a clinician. A combination of subjective data (e.g. sleep diaries and questionnaires) and objective data (actigraphy to measure sleep disturbance via the GENEActiv wrist-worn device) will be used to measure recovery from TBI and sleep disturbance.
Part 3
Part 3 - Interviews 'Part 3' will consist of semi-structured interviews with a sub-sample of participants from Parts 1 and 2. The purpose of this study will be to understand and explore the human experience of sleep disturbance and recovery in TBI.
结局指标
主要结局
Functional outcome
时间窗: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1 - 28
Standardised and validated questionnaire: Extended Glasgow Outcome Score (GOSE)
Functional outcome
时间窗: Part 1: 3 and 6 months post-injury Part 2: At any point between Day 1-28
Standardised and validated questionnaire: Quality of Life after Brain injury (QOLIBRI)
次要结局
- Mental health outcome(Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28)
- Rehabilitation engagement outcome(For Part 2: At any point between Day 1-28)
- Subjective sleep disturbance outcome(Part 1: 3 and 6 months post-injury For Part 2: At any point between Day 1-28)