Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Subjective assessments
研究概览
简要总结
Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. However, the sleep-wake cycle is rarely, if ever, evaluated in patients with TBI and consciousness disorders within Post-Resuscitation Rehabilitation Units (SRPR). Caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. This expertise deserves to be validated using objective sleep assessment tools (actigraphy). If proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within SRPRs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Admission to the Post-Resuscitation Rehabilitation Unit or the Neurological Intensive Care Unit
- •Consciousness disorders: Vegetative State or Minimally Conscious State (according to the CRS-R)
- •Traumatic brain injury
- •Patient aged 18 years or older
- •Presence of relatives able to express non-opposition to the study
- •Subjects affiliated with a social security scheme (or beneficiaries)
排除标准
- •Admission for status epilepticus
- •Individuals admitted to a healthcare or social care facility for purposes other than research
- •Adults under legal protection measures (guardianship, conservatorship)
- •Individuals not affiliated with a social security scheme or not benefiting from a similar scheme
研究组 & 干预措施
Patients in a vegetative state
干预措施: Actimetry (Other)
Patients in a vegetative state
干预措施: Subjective assessments (Other)
Patients in a vegetative state
干预措施: questionnaire (Other)
Patients in a minimally conscious state
干预措施: Actimetry (Other)
Patients in a minimally conscious state
干预措施: Subjective assessments (Other)
Patients in a minimally conscious state
干预措施: questionnaire (Other)
结局指标
主要结局
Subjective assessments
时间窗: during 104 consecutive hours after enrollment
Actimetry
时间窗: during 104 consecutive hours after enrollment
次要结局
- Coma Recovery Scale-Revised(6 months after the start of study)
- Glasgow Coma Scale assessment(6 months after the start of study)
- Glasgow Outcome Scale-Extended assessment(3 months after the start of study)
- Montreal Cognitive Assessment(6 months after the start of study)
- Short Form 36 assessment(6 months after the start of study)
- Montreal Cognitive Assessment(3 months after the start of study)
- Short Form 36 assessment(3 months after the start of the study)
- Coma Recovery Scale-Revised(once a day for 6 to 5 days)
- Coma Recovery Scale-Revised(3 months after the start of study)
- Glasgow Coma Scale assessment(once a day for 6 to 5 days)
- Glasgow Coma Scale assessment(3 months after the start of study)
- Glasgow Outcome Scale-Extended assessment(6 months after the start of study)