Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 5:42 AM
Study NCT ID:
NCT04909112
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2021-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olfactory and Taste Disturbances in Sjogren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D013651', 'term': 'Taste Disorders'}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olfactory detection thresholds for Phenyl-ethyl alcohol', 'timeFrame': 'Day 0', 'description': 'Successive dilutions of odorants by a factor 2 will be realized with distilled water as solvent.\n\nThe odorant stimulus will be presented in a white glass bottle filled with 4 ml of liquid. The bottle will be presented for 3 seconds, medially 1 cm under both nostrils. Odour thresholds will be assessed using an ascending staircase, binary (stimulus vs. blank) forced-choice procedure, with inter-trial intervals of 90 seconds. The two bottles will presented to the subject in random order. After sniffing each stimulus, the participant will be asked to identify the one who smelled stronger. An incorrect choice will led to increase the concentration of the stimulus in the next trial. The dilution step at which the odorant stimulus will be first detected correctly three times in a row will be recorded as the detection threshold.'}, {'measure': 'Olfactory detection thresholds for Butanol', 'timeFrame': 'Day 0', 'description': 'Successive dilutions of odorants by a factor 2 will be realized with distilled water as solvent.\n\nThe odorant stimulus will be presented in a white glass bottle filled with 4 ml of liquid. The bottle will be presented for 3 seconds, medially 1 cm under both nostrils. Odour thresholds will be assessed using an ascending staircase, binary (stimulus vs. blank) forced-choice procedure, with inter-trial intervals of 90 seconds. The two bottles will presented to the subject in random order. After sniffing each stimulus, the participant will be asked to identify the one who smelled stronger. An incorrect choice will led to increase the concentration of the stimulus in the next trial. The dilution step at which the odorant stimulus will be first detected correctly three times in a row will be recorded as the detection threshold.'}, {'measure': 'Olfactory detection thresholds for Pyridine', 'timeFrame': 'Day 0', 'description': 'Successive dilutions of odorants by a factor 2 will be realized with distilled water as solvent.\n\nThe odorant stimulus will be presented in a white glass bottle filled with 4 ml of liquid. The bottle will be presented for 3 seconds, medially 1 cm under both nostrils. Odour thresholds will be assessed using an ascending staircase, binary (stimulus vs. blank) forced-choice procedure, with inter-trial intervals of 90 seconds. The two bottles will presented to the subject in random order. After sniffing each stimulus, the participant will be asked to identify the one who smelled stronger. An incorrect choice will led to increase the concentration of the stimulus in the next trial. The dilution step at which the odorant stimulus will be first detected correctly three times in a row will be recorded as the detection threshold.'}], 'secondaryOutcomes': [{'measure': 'Taste detection thresholds for salty taste', 'timeFrame': 'Day 0', 'description': 'Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.'}, {'measure': 'Taste detection thresholds for sweet taste', 'timeFrame': 'Day 0', 'description': 'Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.'}, {'measure': 'Taste detection thresholds for sour taste', 'timeFrame': 'Day 0', 'description': 'Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.'}, {'measure': 'Taste detection thresholds for bitter taste', 'timeFrame': 'Day 0', 'description': 'Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.'}, {'measure': 'Taste detection thresholds for trigeminal stimuli', 'timeFrame': 'Day 0', 'description': 'Taste strips will be placed on the tongue. Each strip contains a stimulus at different concentrations. Patient will be asked if he/she perceive the taste.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Sjogren's syndrome", 'olfactory disorder', 'taste disorder', '(intra-nasal and oral) trigeminal impairments'], 'conditions': ["Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': 'Sjögren syndrome is an autoimmune disease, responsible for xerostomia and xerophthalmia. Other organs and tissues can be affected: the skin, vaginal and nasal mucous membranes. As well, olfactory disorders have been also described in Sjögren syndrome.\n\nXerostomia often causes significant functional impairment of taste function. Impairment of taste function has been poorly evaluated in Sjögren syndrome like olfactory or (intra-nasal and oral) trigeminal disorders.', 'detailedDescription': "The aim of the study is to evaluate olfactory, taste (intra-nasal and oral) trigeminal functions in patients with Sjogren's syndrome compared to patients without sicca syndrome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* group 1 : patients with Sjogren's syndrome\n* group 2: patients without sicca syndrome\n* older than 18 years old\n* consenting to participate to the study\n\nExclusion Criteria:\n\n* smoking patients\n* patients with stomatitis\n* patients with upper respiratory tract infection"}, 'identificationModule': {'nctId': 'NCT04909112', 'acronym': 'TOG_SJOGREN', 'briefTitle': "Olfactory and Taste Disturbances in Sjogren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': "Olfactory and Taste Disturbances in Sjogren's Syndrome", 'orgStudyIdInfo': {'id': '2021-007-TOG_SJOGREN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "group 1: patients with Sjogren's syndrome", 'description': "Patients with Sjogren's syndrome", 'interventionNames': ['Other: Evaluation of olfactory function', 'Other: Evaluation of taste function', 'Other: Evaluation of (intra-nasal and oral) trigeminal functions']}, {'type': 'OTHER', 'label': 'group 2: patients without sicca syndrome', 'description': 'Patients without sicca syndrome', 'interventionNames': ['Other: Evaluation of olfactory function', 'Other: Evaluation of taste function', 'Other: Evaluation of (intra-nasal and oral) trigeminal functions']}], 'interventions': [{'name': 'Evaluation of olfactory function', 'type': 'OTHER', 'description': 'Evaluation of olfactory function using olfactory detection thresholds', 'armGroupLabels': ["group 1: patients with Sjogren's syndrome", 'group 2: patients without sicca syndrome']}, {'name': 'Evaluation of taste function', 'type': 'OTHER', 'description': 'Evaluation of taste function using taste detection thresholds', 'armGroupLabels': ["group 1: patients with Sjogren's syndrome", 'group 2: patients without sicca syndrome']}, {'name': 'Evaluation of (intra-nasal and oral) trigeminal functions', 'type': 'OTHER', 'description': 'Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.', 'armGroupLabels': ["group 1: patients with Sjogren's syndrome", 'group 2: patients without sicca syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'country': 'France', 'facility': 'Université de Reims Champagne-Ardenne', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Clovis FOGUEM, MD', 'role': 'CONTACT', 'email': 'Clovis.foguem@chu-reims.fr', 'phone': '03 26 58 71 45'}], 'overallOfficials': [{'name': 'Clovis FOGUEM, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Reims Champagne-Ardenne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}