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临床试验/NCT07596186
NCT07596186进行中(未招募)不适用

Passive Digital Monitoring for the Detection of Cognitive Decline How Patterns of Behavior May Predict Dementia and Alzheimer's

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
98
试验地点
1
主要终点
Prediction model of mobile device data, collected for 9 months of lower scores in Neurotrax cognitive assessment compared to baseline evaluation.

研究概览

简要总结

The study will recruit 100 participants aged 65+ residing in assisted living facilities. Eligible participants will undergo an initial cognitive assessment to document their baseline cognitive status using cognitive tests conducted either in their assisted living facility or at Soroka Medical Center. An app designed for research data collection (Aware-Light) will be installed on participants' mobile devices, collecting data only after participants provide consent. Over three months, the app will automatically gather sensor data, including movement data from the accelerometer, orientation data from the gravity sensor, rotation data from the gyroscope, proximity data for measuring distance from nearby objects, ambient light levels from the light sensor, and typing dynamics such as typing frequency and duration without recording actual text. The app will also track app usage, including activation, pauses, closures, background activity, notifications, and crashes, as well as air pressure through the barometer, phone capabilities through the telephony detector, and screen states such as on, locked, or off. It will log communication events such as calls and messages without recording personal details, monitor vehicle speed through the linear accelerometer, track rotation angles through the rotation detector, and identify significant movements like walking, cycling, or traveling. No typed data, such as passwords, will be collected. After one month, the research team will contact participants to ensure the app functions correctly. After three months, participants will undergo a second cognitive assessment, and the app will be uninstalled.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65 and over
  • Clalit HMO members.
  • Without a known diagnosis of dementia
  • Uses Android mobile phones and writes text messages

排除标准

  • A known diagnosis of dementia
  • Uses IOS mobile.
  • Doesn't write text messages

结局指标

主要结局

Prediction model of mobile device data, collected for 9 months of lower scores in Neurotrax cognitive assessment compared to baseline evaluation.

时间窗: Baseline and 9 Month after

Mobile device sensor data

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gal Ifergane MD

Head of Neurology Department

Soroka University Medical Center

研究点 (1)

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