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Clinical Trials/NCT06121960
NCT06121960CompletedNot Applicable

Evaluation of Respiratory Function During Self-induced Cognitive Trance

Centre Hospitalier Metropole Savoie1 site in 1 country9 target enrollmentStarted: May 26, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
1
Primary Endpoint
FEV during a state of self-induced cognitive trance

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Masking Description

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)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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).

Arms & Interventions

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.

Intervention: spirometry (Diagnostic Test)

Outcomes

Primary Outcomes

FEV during a state of self-induced cognitive trance

Time Frame: 3 month

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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