Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02508220
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-07-23', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of tinnitus on VAS', 'timeFrame': '30 minutes after intervention'}, {'measure': 'Change of Clinical global impression scale', 'timeFrame': '30 minutes after intervention'}], 'secondaryOutcomes': [{'measure': 'Audiometry measured in dB HL', 'timeFrame': 'within one hour before intervention', 'description': 'measured in dB HL'}, {'measure': 'Minimum Masking Level measured in dB HL', 'timeFrame': 'within one hour before intervention', 'description': 'measured in dB HL'}, {'measure': 'Tinnitus Matching', 'timeFrame': 'within one hour before intervention', 'description': 'Frequency measured in Hz'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Tinnitus']}, 'descriptionModule': {'briefSummary': 'The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic tinnitus with a duration \\> 6 months\n* medical examination by an ENT specialist\n* sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires\n* VAS score \\>4 points\n\nExclusion Criteria:\n\n* vascular tinnitus\n* muscular tinnitus\n* conductive hearing loss\n* previous experience with oxytocin nasal spray\n* additional medications during the intervention'}, 'identificationModule': {'nctId': 'NCT02508220', 'briefTitle': 'Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus', 'orgStudyIdInfo': {'id': 'Uni-Reg-Oxy-Tin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Oxy-Placebo', 'description': 'Syntocinon first, Placebo second 2 puffs in each nostril', 'interventionNames': ['Drug: Syntocinon', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Placebo-Oxy', 'description': 'Placebo first, Syntocinon second 2 puffs in each nostril', 'interventionNames': ['Drug: Syntocinon', 'Drug: Placebo']}], 'interventions': [{'name': 'Syntocinon', 'type': 'DRUG', 'otherNames': ['Oxytocin'], 'description': 'Oxytocin nasal spray', 'armGroupLabels': ['Oxy-Placebo', 'Placebo-Oxy']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['distilled water'], 'description': 'distilled water in nasal spray', 'armGroupLabels': ['Oxy-Placebo', 'Placebo-Oxy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Berthold Langguth, MD, Ph.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otosul -Otorrinolaringologia Sul-Fluminense', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair of the Tinnitus centrum Regensburg', 'investigatorFullName': 'Berthold Langguth, MD, Ph.D.', 'investigatorAffiliation': 'University of Regensburg'}}}}