Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 6:49 PM
Study NCT ID:
NCT06121960
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Respiratory Function During Self-induced Cognitive Trance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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)'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, monocentric, non-randomized, open-label study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of forced exhaled volume in one second between pre and post phase of cognitive transe'}], 'secondaryOutcomes': [{'measure': 'PEF during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of PEF between pre, per and post phase of cognitive transe'}, {'measure': 'DEM25/50/75 during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of DEM25/50/75 between pre, per and post phase of cognitive transe'}, {'measure': 'inspiratory capacity during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of inspiratory capacity between pre, per and post phase of cognitive transe'}, {'measure': 'respiratory rate during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of respiratory rate between pre, per and post phase of cognitive transe'}, {'measure': 'SpO2 during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of SpO2 between pre, per and post phase of cognitive transe'}, {'measure': 'FVC during a state of self-induced cognitive trance', 'timeFrame': '3 month', 'description': 'variation of FVC between pre, per and post phase of cognitive transe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spirometry', 'TCAI (Cognitive-induced trance)'], 'conditions': ['Respiratory Function']}, 'descriptionModule': {'briefSummary': '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)\n\nThe main question:\n\nStudy the significant variation of FEV1 before, during, or after the state of self-induced cognitive trance', 'detailedDescription': 'Primary objective : Study the significant variation of FEV1 before, during, or after the state of self-induced cognitive trance judgment criteria:\n\nSignificant variations in:\n\nPEF 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Person over 18 years old\n* 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)\n* Person affiliated with social security or beneficiary of such a scheme.\n* Person having given, in writing, their free and informed consent to participate in the study\n\nExclusion Criteria:\n\n* Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.\n* Exclusion period for other studies\n* Person likely, according to the investigator's assessment, not to be cooperative or respectful of the obligations inherent in participation in the study\n* Person with a psychiatric, neurological or cardiovascular disease.\n* Person with a chronic respiratory disease, for example: asthma, COPD, interstitial lung disease, bronchial dilation, cystic fibrosis,\n* Person with a history of exercise-induced bronchospasm.\n* Person taking inhaled treatments (corticotherapy, bronchodilators, anticholinergics)\n* Pregnant woman (declarative)."}, 'identificationModule': {'nctId': 'NCT06121960', 'acronym': 'SPIROTRANSE', 'briefTitle': 'Evaluation of Respiratory Function During Self-induced Cognitive Trance', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Metropole Savoie'}, 'officialTitle': 'Evaluation of Respiratory Function During Self-induced Cognitive Trance', 'orgStudyIdInfo': {'id': 'CHMS22009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventionnal', 'description': '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.', 'interventionNames': ['Diagnostic Test: spirometry']}], 'interventions': [{'name': 'spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Inclusion visit:\n\nPerforming spirometry.\n\nVisit 2 (in the month following the inclusion visit):\n\nInduction 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', 'armGroupLabels': ['Interventionnal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73011', 'city': 'Chambéry', 'state': 'Savoie', 'country': 'France', 'facility': 'Centre Hospitalier Metropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}], 'overallOfficials': [{'name': 'Pierre IDEE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CH Metropole Savoie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Metropole Savoie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}