Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 4:22 PM
Study NCT ID:
NCT07334002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2025-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D001621', 'term': 'Betahistine'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turkish version of the Tinnitus Disability Questionnaire (THI)', 'timeFrame': '3 months'}, {'measure': 'SF-12 (short form)', 'timeFrame': '3 months'}, {'measure': 'Tinnitus severity according to VAS (visual analog scale)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neural Therapy of Huneke', 'Tinnitus'], 'conditions': ['Tinnitus', 'Neural Therapy of Huneke']}, 'descriptionModule': {'briefSummary': 'A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus.\n\nThe study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.', 'detailedDescription': 'All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).\n\nExclusion Criteria:\n\n* Patients with a disease that may cause objective tinnitus,\n\n * Otosclerosis,\n * Chronic otitis media,\n * Acoustic tumor,\n * Meniere's disease,\n * History of ear surgery or head trauma, and those with neuropsychiatric diseases.\n\nAlso:\n\n* Patients who have had ear surgery,\n* Permanent hearing loss (total),\n* Severe cardiovascular system failure, uncontrolled arrhythmia,\n* Severe renal failure, or liver failure"}, 'identificationModule': {'nctId': 'NCT07334002', 'briefTitle': 'The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'A Randomized, Single-blind, Controlled Trial to Evaluate the Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus', 'orgStudyIdInfo': {'id': '16.02.2021 / 3158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'interventionNames': ['Procedure: Neural Therapy of Huneke']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Drug: Betahistine 24 mg bid (Betaserc)']}], 'interventions': [{'name': 'Neural Therapy of Huneke', 'type': 'PROCEDURE', 'description': 'The aim for tinnitus and facial pain is to regulate the trigeminal system and autonomic balance.\n\nConcentration used: Lidocaine 0.5%.\n\nThe auriculotemporal, infraorbital, zygomaticotemporal, and stellate regions were targeted.\n\nPuncture applications: 0.3-0.5 mL will be administered behind the ear, around the mastoid process, behind the tragus, and in the temporomandibular region.\n\nIf necessary, the stellate ganglion area can be supplemented with regulation injections.\n\nNegative aspiration and aseptic technique will be applied before each application.\n\nTransient mild dizziness or local redness may occur after application.\n\nTo avoid the risk of systemic toxicity, the total dose should generally not exceed a maximum of 200 mg of lidocaine.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Betahistine 24 mg bid (Betaserc)', 'type': 'DRUG', 'description': 'Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Roza Jizel Dağdelen, MD', 'role': 'CONTACT', 'email': 'rozadagdelen@gmail.com', 'phone': '+90 212 373 50 00'}, {'name': 'Jülide Öncü Alptekin, Professor Doctor, MD', 'role': 'CONTACT', 'email': 'julideoncu@yahoo.com', 'phone': '+90507 231 6817'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor , Assistant Researcher', 'investigatorFullName': 'Roza Jizel Dagdelen MD', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}