Evaluation of Respiratory Function During Self-induced Cognitive Trance

NCT06121960 | Completed

• 1 other identifier: CHMS22009
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Function

Keywords

spirometry; TCAI (Cognitive-induced trance)

Outcome Measures

Primary Outcomes (1)

• FEV during a state of self-induced cognitive trance

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

  3 month

Secondary Outcomes (6)

• PEF during a state of self-induced cognitive trance

  3 month

• DEM25/50/75 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

• SpO2 during a state of self-induced cognitive trance

  3 month

Study Arms (1)

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.

Diagnostic Test: spirometry

Interventions

spirometry DIAGNOSTIC_TEST

Inclusion visit: Performing spirometry. Visit 2 (in the month following the inclusion visit): Induction of a self-induced cognitive trance by the participant; performance of spirometry before, during the trance then 8 minutes after the end of the trance Actimetry during trance

Interventionnal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.
• 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).

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

Centre Hospitalier Metropole Savoie

Chambéry, Savoie, 73011, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pierre IDEE

  CH Metropole Savoie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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)
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, monocentric, non-randomized, open-label study.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: November 8, 2023
• Study Start: May 26, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 7, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)