Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT01727492
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Noise-induced Damage by Use of Antioxidants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D006317', 'term': 'Hearing Loss, Noise-Induced'}], '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'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D034381', 'term': 'Hearing Loss'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Decrease of temporary threshold shift in antioxidant trials compared to placebo trials', 'description': 'A limited number of participants will have audiological testing (audiometry including high frequency audiometry, speech-in-noise testing and otoacoustic emissions) prior to the musical event as well as the morning after noise exposure in order to measure the effects of antioxidants on the hearing thresholds and hearing performance.'}], 'primaryOutcomes': [{'measure': 'Protection against noise-induced tinnitus due to antioxidants', 'description': 'Antioxidants protect against temporary threshold shift. The most prevalent cause of noise-induced tinnitus is noise-induced hearing loss. Therefore, it is assumed that the preventive intake of antioxidants prior to a loud event, might protect against threshold shift as well as noise-induced tinnitus.\n\nA 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected.'}], 'secondaryOutcomes': [{'measure': 'Change of tinnitus duration', 'description': 'It is expected that with the intake of antioxidants noise-induced tinnitus is prevented or reduced after loud music exposure. In addition, it is expected that the tinnitus persistence is shortened compared to the placebo arm.'}]}, 'conditionsModule': {'keywords': ['prevention', 'noise-induced tinnitus', 'noise-induced hearing loss', 'young population'], 'conditions': ['Noise-induced Tinnitus', 'Noise-induced Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '24708640', 'type': 'DERIVED', 'citation': 'Gilles A, Ihtijarevic B, Wouters K, Van de Heyning P. Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial. Trials. 2014 Apr 5;15:110. doi: 10.1186/1745-6215-15-110.'}]}, 'descriptionModule': {'briefSummary': 'The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-25 years old\n* Temporary tinnitus after noise exposure: loudness \\>5 on a VAS\n\nExclusion Criteria:\n\n* middle ear problems\n* Allergy for magnesium or n-acetylcystein\n* Use of hearing protection when going out'}, 'identificationModule': {'nctId': 'NCT01727492', 'briefTitle': 'Prevention of Noise-induced Damage by Use of Antioxidants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'orgStudyIdInfo': {'id': '12/18/172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'sugar pill'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antioxidantia', 'description': 'Dosage: 600mg n-acetylcystein and 200mg magnesium intake: 1 hour before leisure noise exposure above 100dB of at least 30 minutes frequency: 4 separate events (2x placebo, 2x antioxidants)', 'interventionNames': ['Drug: Antioxidantia']}], 'interventions': [{'name': 'Antioxidantia', 'type': 'DRUG', 'armGroupLabels': ['Antioxidantia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Antwerp', 'state': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Annick Gilles, Master', 'role': 'CONTACT', 'email': 'annick.gilles@uza.be', 'phone': '32 821 32 57'}, {'name': 'Annick Gilles, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'centralContacts': [{'name': 'Annick Gilles, Master', 'role': 'CONTACT', 'email': 'annick.gilles@uza.be', 'phone': '32 3 821 52 80'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ethics Comittee UZ Antwerpen', 'investigatorFullName': 'Ethisch Comité UZ Antwerpen', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}