Evaluation of Respiratory Function During Self-induced Cognitive Trance (SPIROTRANSE)

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

Study Overview

• Status: Completed
• Conditions: Respiratory Function
• Intervention / Treatment: Diagnostic test: spirometry

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Savoie
    • Chambéry, Savoie, France, 73011
      • Centre Hospitalier Metropole Savoie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventionnal; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEF during a state of self-induced cognitive trance	variation of PEF between pre, per and post phase of cognitive transe	3 month
DEM25/50/75 during a state of self-induced cognitive trance	variation of DEM25/50/75 between pre, per and post phase of cognitive transe	3 month
inspiratory capacity during a state of self-induced cognitive trance	variation of inspiratory capacity between pre, per and post phase of cognitive transe	3 month
respiratory rate during a state of self-induced cognitive trance	variation of respiratory rate between pre, per and post phase of cognitive transe	3 month
SpO2 during a state of self-induced cognitive trance	variation of SpO2 between pre, per and post phase of cognitive transe	3 month
FVC during a state of self-induced cognitive trance	variation of FVC between pre, per and post phase of cognitive transe	3 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie
• Investigators: Study Director: Pierre IDEE, CH Metropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: spirometry; TCAI (Cognitive-induced trance)
• Other Study ID Numbers: CHMS22009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No