Evaluation of Respiratory Function During Self-induced Cognitive Trance

Respiratory Function Clinical Trial

— SPIROTRANSE  

Official title:

Evaluation of Respiratory Function During Self-induced Cognitive Trance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121960
• Other study ID #: CHMS22009
• Status: Completed
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: March 7, 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Metropole Savoie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 7, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Respiratory Function

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Metropole Savoie	Chambéry	Savoie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PEF during a state of self-induced cognitive trance	variation of PEF between pre, per and post phase of cognitive transe	3 month
Secondary	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
Secondary	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
Secondary	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
Secondary	SpO2 during a state of self-induced cognitive trance	variation of SpO2 between pre, per and post phase of cognitive transe	3 month
Secondary	FVC during a state of self-induced cognitive trance	variation of FVC between pre, per and post phase of cognitive transe	3 month