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临床试验/NCT06121960
NCT06121960已完成不适用

Evaluation of Respiratory Function During Self-induced Cognitive Trance

Centre Hospitalier Metropole Savoie1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年5月26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
9
试验地点
1
主要终点
FEV during a state of self-induced cognitive trance

研究概览

简要总结

The goal of this Prospective, monocentric, non-randomized, open-label study aimed at evaluating the variation of FEV1 during a state of self-induced cognitive trance participant population: Person with expertise in the practice of TCAI can be inclued. (at least 6 months, in order to be able to control the depth of the trance and to have a motor control allowing the realization of a spirometry)

The main question:

Study the significant variation of FEV1 before, during, or after the state of self-induced cognitive trance

详细描述

Primary objective : Study the significant variation of FEV1 before, during, or after the state of self-induced cognitive trance judgment criteria:

Significant variations in:

PEF PEF25 PEF50 PEF75 FVC Inspiratory capacity, SpO2 Respiratory rate before, during, or after the self-induced cognitive trance state Evolution of the feeling of self-efficacy, assessed by questionnaire

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

Person with expertise in the practice of TCAI. (at least 6 months, in order to be able to control the depth of the trance and to have a motor control allowing the realization of a spirometry)

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

  • •Person over 18 years old
  • •Person with expertise in the practice of TCAI. (at least 6 months, in order to be able to control the depth of the trance and to have a motor control allowing the realization of a spirometry)
  • •Person affiliated with social security or beneficiary of such a scheme.
  • •Person having given, in writing, their free and informed consent to participate in the study

排除标准

  • •Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.
  • •Exclusion period for other studies
  • •Person likely, according to the investigator's assessment, not to be cooperative or respectful of the obligations inherent in participation in the study
  • •Person with a psychiatric, neurological or cardiovascular disease.
  • •Person with a chronic respiratory disease, for example: asthma, COPD, interstitial lung disease, bronchial dilation, cystic fibrosis,
  • •Person with a history of exercise-induced bronchospasm.
  • •Person taking inhaled treatments (corticotherapy, bronchodilators, anticholinergics)
  • •Pregnant woman (declarative).

研究组 & 干预措施

Interventionnal

Experimental

Measure DEP, DEM25, DEM 50, DEM 75, FVC, Inspiratory capacity, SpO2, Respiratory rate before, during, or after the state of self-induced cognitive trance Evolution of the feeling of self-efficacy, assessed by questionnaire.

干预措施: spirometry (Diagnostic Test)

结局指标

主要结局

FEV during a state of self-induced cognitive trance

时间窗: 3 month

variation of forced exhaled volume in one second between pre and post phase of cognitive transe

次要结局

  • PEF during a state of self-induced cognitive trance(3 month)
  • inspiratory capacity during a state of self-induced cognitive trance(3 month)
  • respiratory rate during a state of self-induced cognitive trance(3 month)
  • DEM25/50/75 during a state of self-induced cognitive trance(3 month)
  • SpO2 during a state of self-induced cognitive trance(3 month)
  • FVC during a state of self-induced cognitive trance(3 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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