Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Neuropsychiatric (mental health) symptoms at baseline
研究概览
简要总结
The two most common causes of brain injury are stroke and trauma. Both sleep and mental health problems are common after brain injury; we will investigate whether there is a relationship between poor sleep quality and worse mental health in this group. We will also follow patients up, at approximately three-monthly intervals until one year after injury, to see how sleep and mental health symptoms change over time and with recovery.
We will assess sleep in detail using questionnaires, a sleep monitor worn on the wrist, a portable brain activity sensor, and a sleep mat. We will assess mental health (neuropsychiatric) symptoms using questionnaires.
Participants will be asked to complete these assessments at baseline and at approximately 3-monthly intervals until they reach 12 months post-injury.
This data will allow us to explore the types of sleep disruption seen after brain injury and examine the association between sleep and mental health symptoms.
详细描述
This is a cross-sectional and longitudinal observational cohort study to assess the relationship between sleep quality and neuropsychiatric symptoms in adults within 12 months of an acquired brain injury, including traumatic brain injury (TBI), ischaemic stroke or haemorrhage. We hypothesise that participants with poor sleep quality will have worse neuropsychiatric (mental health) symptoms and slower recovery.
Participants will be identified at least one week, but less than 12 months, after brain injury from: a) National Health Service (NHS) sites; b) advertisements; and c) previous studies where patients have consented to be contacted about future studies.
The primary aim is to test whether adults with acquired brain injury and poor sleep quality (defined as a cut-off of >5 on the Pittsburgh Sleep Quality Index; PSQI) have a greater neuropsychiatric symptom burden (assessed with the diagnostic and statistical manual of mental disorder ver sion (DSM-5) Cross-Cutting Measure Level 1 Total Score) than those with good subjective sleep quality.
Secondary outcomes will test whether both self-reported and objective markers of sleep disruption (derived from actigraphy, brain activity and sleep mat data) relate to neuropsychiatric symptoms over time.
Two optional sub-studies will assess: a) long term sleep mat derived metrics (the participant will be asked to have a sleep mat on their bed at home for one year), and b) the association between sleep and changes in motor function over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent for participation in the study.
- •Aged 18 years or above.
- •At least one week, but less than 12 months post-injury
- •Clinical diagnosis of acquired brain injury (stroke, haemorrhage or traumatic).
- •Participants with Traumatic Brain Injury will have a Mild (probable) or Moderate-severe (definite) brain injury according to the Mayo classification
- •Participants must be willing to consent to us contacting their general practitioner (GP) or direct care team if we have concerns about their mental health
排除标准
- •Brain injury not caused by trauma, haemorrhage or stroke
- •Previous brain injury.
- •Other relevant neurological conditions which could affect outcome measures (e.g., Parkinson's or Alzheimer's disease)
- •No stable and suitable place to sleep
研究组 & 干预措施
Adults with acquired brain injury
We will follow adults with either stroke or traumatic brain injury for one year post-injury to examine the associations between sleep, mental health and motor recovery.
结局指标
主要结局
Neuropsychiatric (mental health) symptoms at baseline
时间窗: Baseline (first assessment, obtained within 12 months of acquired brain injury)
Assessed using the Diagnostic and Statistical Manual version 5 (DSM-5) Cross-Cutting Measure questionnaire level 1 total score. Range 0-92, higher scores indicate worse neuropsychiatric symptoms.
Self reported sleep quality at baseline
时间窗: Baseline (first assessment, obtained within 12 months of acquired brain injury)
Assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Range 0-21, higher scores indicate worse sleep quality.
次要结局
- Neuropsychiatric (mental health) symptoms(Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant))
- Symptoms of Depression(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Sleep Fragmentation Index(Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Slow wave sleep (SWS) amplitude(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Sleep spindle power(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Time in each stage of sleep(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Sleep continuity measures from a mattress sensor(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Symptoms of Anxiety(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Symptoms of Post-traumatic stress disorder(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Symptoms of Insomnia(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Self reported sleep quality(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Fatigue symptoms(Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)
- Sleep Regularity Index(Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).)