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临床试验/NCT06633978
NCT06633978
招募中
不适用

A Pilot Study of the Impact of Personalized Digital Meditation on Improving Sleep and Reducing Stress in MCI

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 90 人2024年9月10日

概览

阶段
不适用
干预措施
MediTrain
疾病 / 适应症
MCI
发起方
University of California, San Francisco
入组人数
90
试验地点
1
主要终点
Mean change on the Continuous Performance Task (CPT) over time
状态
招募中
最后更新
2个月前

概览

简要总结

The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.

注册库
clinicaltrials.gov
开始日期
2024年9月10日
结束日期
2026年8月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • comfortably ambulatory healthy physical condition
  • normal or corrected to normal visual
  • auditory acuity
  • fluency in spoken English
  • Between 60-85 years old
  • No neurological or psychiatric disorders
  • No substance abuse
  • Not taking anti-depressants
  • Not taking anti-anxiety medication
  • No history of seizures

排除标准

  • 未提供

研究组 & 干预措施

MediTrain

干预措施: MediTrain

MediTrain

干预措施: wrist worn multi-sensor watches

MediTrain

干预措施: Sleep monitor

结局指标

主要结局

Mean change on the Continuous Performance Task (CPT) over time

时间窗: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

Mean change in sleep quality

时间窗: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

Mean change in sleep quality (i.e., total sleep time / time in bed, therefore this measure incorporates latency to sleep onset, total sleep time, wake after sleep onset and early morning waking, with higher numbers associated with better sleep) over time \[Time Frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants\]

Mean change in measures of stress reactivity over time

时间窗: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task

次要结局

  • Mean change in Telomere length (quantified in peripheral blood cells) over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)
  • Mean change on a distracted attention task over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)
  • Mean change in Frontal Theta Power over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)
  • Mean change in resting state networks over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)

研究点 (1)

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