Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 2:47 PM
Study NCT ID:
NCT02353650
Status:
UNKNOWN
Last Update Posted:
2016-04-18
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014373', 'term': 'Tuberculin'}, {'id': 'C003741', 'term': 'ubiquinol'}], 'ancestors': [{'id': 'D000942', 'term': 'Antigens, Bacterial'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Functional Index', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Audiometric tresholds test', 'timeFrame': '2 months'}, {'measure': 'Tinnitus Analysis _ loudness matches', 'timeFrame': '2 months'}, {'measure': 'Tinnitus Analysis_Minimal masking level', 'timeFrame': '2 months'}, {'measure': 'Visual Analogue Scale of loudness', 'timeFrame': '2 months'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '2 months'}, {'measure': 'Hyperacusis Questionnaire', 'timeFrame': '2 months'}]}, 'conditionsModule': {'keywords': ['Q10', 'ubiquinol'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic non-pulsatile tinnitus \\> 3 months\n* tinnitus has a clear otological cause\n* age \\> 18 years\n\nExclusion Criteria:\n\n* pulsatile tinnitus\n* persons who take already Q10\n* pregnancy\n* cervical tinnitus\n* holocranial tinnitus\n* depression\n* mental of neurological disorders\n* history of chemotherapy\n* middle ear diseases'}, 'identificationModule': {'nctId': 'NCT02353650', 'briefTitle': 'The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'orgStudyIdInfo': {'id': '14/27/286'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Q10', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ubiquinol']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sarah Rabau', 'role': 'CONTACT', 'email': 'sarah.rabau@uza.be', 'phone': '003238215235'}], 'facility': 'University hospital of Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ethics Committee', 'investigatorFullName': 'Ethisch Comité UZA', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}