AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Incidence of nights in a confirmation cohort in which RBD episodes are indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch
研究概览
简要总结
dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.
详细描述
The development cohort comprises 30 patients with RBD and 30 matched controls on sex and age with patients RBD.
The confirmation cohort comprises 30 patients with PD. Following a baseline visit comprising standard clinical evaluation and Parkinson questionnaires, participants will undergo daily-life dBM tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. Additionally, PD patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a RBD. The investigation is conducted in four European sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of nights in a confirmation cohort in which RBD episodes are indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch
时间窗: 4 weeks
the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
次要结局
- Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.(4 weeks (for development cohort) and 3 months (for confirmation cohort))
- correlation between a) and b)(4 weeks for a) 3 months for b))
- Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks.(4 weeks (for development cohort) and 3 months (for confirmation cohort))