Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT05227157
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2022-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GOUTMETALSAIN: Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013651', 'term': 'Taste Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D020435', 'term': 'Glossopharyngeal Nerve Diseases'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of the intensity of metallic taste', 'timeFrame': '5 minutes', 'description': 'visual analogue scale (0 to 5); A score of 5 means the highest intensity of metallic taste'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Taste, Metallic'], 'conditions': ['Taste Disorders', 'Sensation Disorders', 'Taste, Metallic', 'Taste Disorder, Glossopharyngeal Nerve']}, 'descriptionModule': {'briefSummary': 'This is a mono center , observational study carried out within otorhinolaryngology department in CH Valence.\n\nThis is a descriptive and exploratory study in healthy volunteers. Based on the hypothesis that Metallic taste is imperfectly assessed, this study will provide a better understanding of the Metallic Taste.', 'detailedDescription': 'The study consists of the application of a swab soaked in iron sulfate at a concentration of 10g/l.\n\neach patient will rate the intensity he/she perceives (on a numerical scale from 1 to 5) at each of the 4 predefined lingual locations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volonteers without olfactory and gustatory disorder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Healthy volunteers\n* Read, write and understand the French language\n* Patient affiliated to a social security system\n* Written and signed informed consent\n\nExclusion Criteria:\n\n* head and Neck cancer history\n* olfactory and gustatory disorder\n* Refusal to participate in research\n* Patient under guardianship, deprived of liberty, safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05227157', 'briefTitle': 'GOUTMETALSAIN: Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Valence'}, 'officialTitle': 'Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'RIPH-CHV-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1: intensity of perception of metallic taste', 'description': 'For this study, there is only one arm: swab with iron sulfate solution at a concentration of 10g/l.\n\nEach subject complete visual scale', 'interventionNames': ['Other: swab with iron sulfate solution']}], 'interventions': [{'name': 'swab with iron sulfate solution', 'type': 'OTHER', 'description': 'measurement of the intensity of perception of metallic taste by affixing a swab iron sulfate solution 10g/l at 4 places on the tongue depending on the glossopharyngeal nerve: tip of the tongue (right and left); base of the tongue (right and left). Visual analogic Scale (0 to 5)', 'armGroupLabels': ['1: intensity of perception of metallic taste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26953', 'city': 'Valence', 'state': 'Drome', 'country': 'France', 'facility': 'Ch Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Valence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}