Clinical trial NCT06121960: Evaluation of Respiratory Function During Self-induced Cognitive Trance
Official title: Evaluation of Respiratory Function During Self-induced Cognitive Trance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Function
Keywords: spirometry
TCAI (Cognitive-induced trance)
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, monocentric, non-randomized, open-label study.
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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).

Primary outcomes:
measure: FEV during a state of self-induced cognitive trance
timeFrame: 3 month
Secondary outcomes:
measure: PEF during a state of self-induced cognitive trance
timeFrame: 3 month
measure: DEM25/50/75 during a state of self-induced cognitive trance
timeFrame: 3 month
measure: inspiratory capacity during a state of self-induced cognitive trance
timeFrame: 3 month
measure: respiratory rate during a state of self-induced cognitive trance
timeFrame: 3 month
measure: SpO2 during a state of self-induced cognitive trance
timeFrame: 3 month
measure: FVC during a state of self-induced cognitive trance
timeFrame: 3 month
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier Metropole Savoie
state: Savoie
Study officials:
affiliation: CH Metropole Savoie
name: Pierre IDEE
role: STUDY_DIRECTOR
References: