Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 3:28 PM
Study NCT ID:
NCT04686695
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2020-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008575', 'term': 'Meniere Disease'}], 'ancestors': [{'id': 'D018159', 'term': 'Endolymphatic Hydrops'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-16', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks', 'timeFrame': 'Day 0 and postintervention at Week 12', 'description': 'Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms'}, {'measure': 'Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks', 'timeFrame': 'Day 0 and postintervention at Week 12', 'description': 'DHI to measure the subjective dizziness symptoms.'}, {'measure': 'Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks', 'timeFrame': 'Day 0 and postintervention at Week 12', 'description': 'Pure Tone Audiometry to measure the audition.'}], 'secondaryOutcomes': [{'measure': 'Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks', 'timeFrame': 'Day 0 and postintervention at Week 12', 'description': 'SF-36 to measure quality of life'}, {'measure': 'Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks', 'timeFrame': 'Day 0 and postintervention at Week 12', 'description': 'Visual scale to measure the subjective ear stuffiness symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcutaneous auricular vagus nerve stimulation'], 'conditions': ['Meniere Disease']}, 'descriptionModule': {'briefSummary': 'Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.\n\nMethods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.\n\nTinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.\n\nA difference of P \\< 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>=18 and Age \\<=70.\n2. Clinical diagnosis of meniere disease.\n\nExclusion Criteria:\n\n1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.\n2. History of Otorhinolaryngology surgery.\n3. Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT04686695', 'briefTitle': 'Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study', 'orgStudyIdInfo': {'id': 'taVNS-MD-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Auricular Vagus Nerve Stimulation', 'interventionNames': ['Device: taVNS']}], 'interventions': [{'name': 'taVNS', 'type': 'DEVICE', 'description': 'taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily.', 'armGroupLabels': ['Transcutaneous Auricular Vagus Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}