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临床试验/NCT06397469
NCT06397469招募中不适用

Optimizing a Closed-loop Digital Meditation Intervention for Remediating Cognitive Decline and Reducing Stress in Older Adults

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
1
主要终点
Change on the Mobile Continuous Performance Task (CPT) over time

研究概览

简要总结

The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

double blind

入排标准

年龄范围
60 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60+ years old (adult)
  • English language fluency
  • owning a smartphone or tablet

排除标准

  • Under 60 years old (minor)

研究组 & 干预措施

MediTrain 30m/day for 6wks

Experimental

Participants will engage with a digital meditation app for the time listed above.

干预措施: MediTrain (Device)

MediTrain 15m/day for 6wks

Experimental

Participants will engage with a digital meditation app for the time listed above.

干预措施: MediTrain (Device)

MediTrain 30m/day for 3wks

Experimental

Participants will engage with a digital meditation app for the time listed above.

干预措施: MediTrain (Device)

MediTrain 15m/day for 3wks

Experimental

Participants will engage with a digital meditation app for the time listed above.

干预措施: MediTrain (Device)

Active Control Group

Active Comparator

An active control application will be used for this arm. The total training experience here will be for 6 weeks (5 days/week), with each training session lasting ~30 minutes (not including self-paced breaks). Here an app that is matched in terms of expectancy of benefits compared to our training groups will be determined by questioning 100 naïve individuals to predict their expected improvement on each cognitive domain across a multitude of possible applications.

干预措施: Worder (Device)

结局指标

主要结局

Change on the Mobile Continuous Performance Task (CPT) over time

时间窗: baseline, immediate follow-up, and at a 6 month follow-up

The CPT is a 23-minute task, where participants are instructed to respond to target stimuli (squares at the top of the screen) and withhold responses to non-target stimuli (squares at the bottom of the screen). Performance will be quantified as: (1) mean reaction times, (2) standard deviation of reaction times (RTV), and (3) d-prime (comparing correct target detections or 'hits' to incorrect non-target detections or 'false alarms').

次要结局

  • Change on the Adaptive Cognitive Evaluation (ACE) over time(baseline, immediate follow-up, and at a 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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