Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 590
- 试验地点
- 2
- 主要终点
- Presence or absence of the disease
研究概览
简要总结
The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.
详细描述
Nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : ADHD (Attention Deficit Disorder / Hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. The duration of the study is 8 years.
Type of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle.
Study design:
- standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales,
- a virtual reality task. The primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales).
The secondary outcomes are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being aged between 7 and 75 years
- •Having signed written informed consent
排除标准
- •Having participated to a clinical trial in the previous 3 months
结局指标
主要结局
Presence or absence of the disease
时间窗: 1 day
Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)
次要结局
- Physiological parameters: Polysomnography (sleep structure (stage %))(1 night)
- Sleepiness scale(1 day)
- BDI-II questionnaire(1 day)
- Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))(1 night)
- Physiological parameters: Polysomnography (total sleep time (min))(1 night)
- IDS-R questionnaire(1 day)
- Acceptability scale(1 day)
- ASRS(1 day)
研究者
Pierre Philip
MD / PhD
University of Bordeaux