Respiratory FunctionSPIROTRANSENCT06121960
Evaluation of Respiratory Function During Self-induced Cognitive Trance
A study testing spirometry in people with Respiratory Function, run by Centre Hospitalier Metropole Savoie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function
- What is being tested?
- spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2023to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Respiratory Function
- Being tested
- spirometry
- Keywords
- spirometry, TCAI (Cognitive-induced trance)
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Secondary outcomes (6)
PEF during a state of self-induced cognitive trance
variation of PEF between pre, per and post phase of cognitive transe
Measured: 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
Measured: 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
Measured: 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
Measured: 3 month
SpO2 during a state of self-induced cognitive trance
variation of SpO2 between pre, per and post phase of cognitive transe
Measured: 3 month
FVC during a state of self-induced cognitive trance
variation of FVC between pre, per and post phase of cognitive transe
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start26 May 2023
- Primary completion1 Jan 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, monocentric, non-randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre IDEE, Study director, CH Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121960
- Sponsor's protocol ID
- 2022-A02686-37
- Acronym
- SPIROTRANSE
- Status last verified
- Oct 2026
- First submitted
- 26 May 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Function During Self-induced Cognitive Trance
- ClinicalTrials.gov ID
- NCT06121960
- Acronym / sponsor ID
- SPIROTRANSE / 2022-A02686-37
- Conditions
- Respiratory Function
- Keywords
- spirometry, TCAI (Cognitive-induced trance)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, monocentric, non-randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Interventionnal | Experimental | Diagnostic Test: spirometryMeasure 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometryInclusion 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 | Diagnostic test | Interventionnal |
Primary outcome
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
6 secondary outcomes
PEF during a state of self-induced cognitive trance
Time frame: 3 month
DEM25/50/75 during a state of self-induced cognitive trance
Time frame: 3 month
inspiratory capacity during a state of self-induced cognitive trance
Time frame: 3 month
respiratory rate during a state of self-induced cognitive trance
Time frame: 3 month
SpO2 during a state of self-induced cognitive trance
Time frame: 3 month
FVC during a state of self-induced cognitive trance
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre IDEE study director
CH Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spirometry in people with Respiratory Function, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV during a state of self-induced cognitive trance (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.