Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-28 @ 10:23 PM
Study NCT ID:
NCT03315156
Status:
UNKNOWN
Last Update Posted:
2017-10-19
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taste Changes in Acute Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taste change in AOM', 'timeFrame': '1 week', 'description': 'change in taste threshold in AOM patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute otitis media', 'AOM', 'Electrogustometer', 'EGM', 'Taste threshold'], 'conditions': ['Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'Detection of taste changes in Acute Otitis Media (AOM) patients.', 'detailedDescription': 'Methods:\n\nTaste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual.\n\nPopulation: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AOM', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral AOM\n\nExclusion Criteria:\n\n* Chronic Otitis Media\n* Pregnancy\n* Patients with lack of judgment'}, 'identificationModule': {'nctId': 'NCT03315156', 'briefTitle': 'Taste Changes in Acute Otitis Media', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Taste Changes in Acute Otitis Media', 'orgStudyIdInfo': {'id': 'TASMC-17-AD-0311-17-TLV-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'patients with AOM', 'interventionNames': ['Diagnostic Test: Electrogustometery']}], 'interventions': [{'name': 'Electrogustometery', 'type': 'DIAGNOSTIC_TEST', 'description': 'Taste assessment using EGM', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ari DeRowe, MD', 'role': 'CONTACT', 'email': 'arid@tlvmc.gov.il', 'phone': '03-6974517'}], 'overallOfficials': [{'name': 'Ari DeRowe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TLVMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}