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OpenTrials
Completed

NCT Number: NCT06121960

Evaluation of Respiratory Function During Self-induced Cognitive Trance

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Metropole Savoie

Chambéry, Savoie, 73011, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. FEV during a state of self-induced cognitive trance

    Time frame: 3 month

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

Secondary outcomes

  1. PEF during a state of self-induced cognitive trance

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 month

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

  6. FVC during a state of self-induced cognitive trance

    Time frame: 3 month

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Acronym: SPIROTRANSE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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