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临床试验/NCT05513846
NCT05513846已完成不适用

Brain Age and Sleep Architecture in Meditators

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Brain Age

研究概览

简要总结

This is a single-center, cross-sectional study that will recruit approximately fifty seven (57) meditators and fifty one (51) controls. Individuals that have learned at least the Shambhavi Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM EEG device, and a sleepimage ring. Participants will be asked to wear the two devices while sleeping for three consecutive weekday nights (Sunday night to Thursday night) and two weekend nights (Friday and Saturday nights). While meditating during the day, participants will only wear the DREEM EEG headband. Participants will also undergo neurocognitive tests from the NIH toolbox during one virtual visit via video call. Meditators who join the study will be asked to invite a control subject to the study, matched for age and comorbidities.

详细描述

Approximately one hundred and eight (108) individuals will undergo three consecutive weekday nights and two weekend nights of EEG and plethysmography recording using the DREEM headband and SleepImage rings, after answering a demographic questionnaire. Out of these 108 participants, the study will aim for 57 meditators and 51 matched controls. Only meditating participants will be asked to perform the most advanced form of meditation among the following three, which are listed from least advanced to most advanced: Shambhavi Mahamudra Kriya, Shoonya Meditation, Samyama Meditation (Breath watching). Participants will be instructed to wear the DREEM EEG headband during their practice of this meditation during each of the five days.

All participants will also be asked to undergo cognitive assessments from the NIH toolbox during a video call. The assessments from the NIH toolbox will last approximately forty-five minutes to one hour.

EEG: The participants will be mailed the DREEM devices and asked to wear them for three consecutive weekday nights and two weekend nights while sleeping. During the day, for each of these five nights, meditating participants will also be asked to wear the device while they sit still with their eyes closed, without trying to meditate, for 10 minutes. This will function as the baseline waking EEG measurement. Immediately following this, participants will be asked to perform their meditation while wearing the DREEM device for a maximum of 30 minutes.

NIH Toolbox:

This study will use select tests from the NIH Toolbox Cognition Battery and from the NIH Toolbox Emotion Battery. All of the tests together will take approximately 45 minutes to 1 hour to complete.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • (Meditators):
  • Previous experience with learning Shambhavi Mahamudra Kriya
  • Age 18 years or older.
  • Lives in the United States barring California
  • Inclusion Criteria (Controls):
  • Age 18 years or older
  • Lives in the United States barring California

排除标准

  • (both groups):
  • Non-English Speaking
  • Night Shift workers

研究组 & 干预措施

Meditation

This is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study.

干预措施: DREEM EEG Device (Device)

Meditation

This is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study.

干预措施: SleepImage Ring (Device)

Control

This is the group that will not have learned Shambhavi Mahamudra Kriya before they are enrolled in the study. They will be invited to the study by the Meditation group.

干预措施: DREEM EEG Device (Device)

Control

This is the group that will not have learned Shambhavi Mahamudra Kriya before they are enrolled in the study. They will be invited to the study by the Meditation group.

干预措施: SleepImage Ring (Device)

结局指标

主要结局

Brain Age

时间窗: Measured for 3 weekday and 3 weekend nights during the data collection period

Brain Age will be calculated using an algorithm from the sleeping EEG. A Brain Age index score will be created for each participant based on an aggregate of the five days of sleeping EEG data. The Brain Age Index is the brain age calculated from the algorithm subtracted by the chronological age of the participant.

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

Balachundhar Subramaniam

Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (1)

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