SPIROTRANSE: Evaluation of Respiratory Function During Self-induced Cognitive Trance

Sponsor
Centre Hospitalier Metropole Savoie (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06121960
Collaborator
(none)
10
1
1
12
0.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: spirometry
N/A

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
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, monocentric, non-randomized, open-label study.Prospective, monocentric, non-randomized, open-label study.
Masking:
None (Open Label)
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)
Primary Purpose:
Basic Science
Official Title:
Evaluation of Respiratory Function During Self-induced Cognitive Trance
Actual Study Start Date :
May 26, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
May 26, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. FEV during a state of self-induced cognitive trance [3 month]

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

Secondary Outcome Measures

  1. PEF during a state of self-induced cognitive trance [3 month]

    variation of PEF between pre, per and post phase of cognitive transe

  2. DEM25/50/75 during a state of self-induced cognitive trance [3 month]

    variation of DEM25/50/75 between pre, per and post phase of cognitive transe

  3. inspiratory capacity during a state of self-induced cognitive trance [3 month]

    variation of inspiratory capacity between pre, per and post phase of cognitive transe

  4. respiratory rate during a state of self-induced cognitive trance [3 month]

    variation of respiratory rate between pre, per and post phase of cognitive transe

  5. SpO2 during a state of self-induced cognitive trance [3 month]

    variation of SpO2 between pre, per and post phase of cognitive transe

  6. FVC during a state of self-induced cognitive trance [3 month]

    variation of FVC between pre, per and post phase of cognitive transe

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Metropole Savoie Chambéry Savoie France 73011

Sponsors and Collaborators

  • Centre Hospitalier Metropole Savoie

Investigators

  • Study Director: Pierre IDEE, CH Metropole Savoie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Metropole Savoie
ClinicalTrials.gov Identifier:
NCT06121960
Other Study ID Numbers:
  • CHMS22009
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Metropole Savoie

Study Results

No Results Posted as of Nov 8, 2023