Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT06614933
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2024-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants will be blinded to which protocol they are receiving during data collection. The investigator responsible for processing HRV data will be blinded to group assignment, and investigators will be blinded to group assignment when conducting qualitative data analysis.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-24', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability measured by tolerability questionnaire', 'timeFrame': 'Up to 3 hours.', 'description': 'Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort)-10 (worst pain imaginable) for comfort.'}, {'measure': 'Tolerability measured by self-report', 'timeFrame': 'Up to 3 hours.', 'description': 'Tolerability will be assessed using semi-structured interviews. Investigators will ask about the sensations experienced and preferences. Participants will self-report their responses.'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate variability (HRV)', 'timeFrame': 'Baseline and up to 3 hours.', 'description': 'HRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. between the ages of 18-80 years\n2. English speaking (must be able to consent and complete the interviews in English)\n\nExclusion Criteria:\n\n1. chronic pain (average intensity \\>2/10 on 0-10 scale, for longer than 3 months)\n2. acute pain of intensity greater than 3/10\n3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)\n4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)\n5. pregnancy\n6. currently taking Buprenorphine or recently stopped taking (within 1 month)\n7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews\n8. implants in the head or neck, cochlear implants, or pacemaker\n9. head or neck metastasis or recent ear trauma\n10. history of epilepsy\n11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).'}, 'identificationModule': {'nctId': 'NCT06614933', 'briefTitle': 'How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?', 'orgStudyIdInfo': {'id': '20240796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biphasic followed by monophasic taVNS group', 'description': 'Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.', 'interventionNames': ['Device: Biphasic transcutaneous auricular vagus nerve stimulation', 'Device: Monophasic transcutaneous auricular vagus nerve stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monophasic followed by biphasic taVNS group', 'description': 'Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.', 'interventionNames': ['Device: Biphasic transcutaneous auricular vagus nerve stimulation', 'Device: Monophasic transcutaneous auricular vagus nerve stimulation']}], 'interventions': [{'name': 'Biphasic transcutaneous auricular vagus nerve stimulation', 'type': 'DEVICE', 'description': 'Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a biphasic current, continuous at 25 Hz, for 1 hour, in-person.', 'armGroupLabels': ['Biphasic followed by monophasic taVNS group', 'Monophasic followed by biphasic taVNS group']}, {'name': 'Monophasic transcutaneous auricular vagus nerve stimulation', 'type': 'DEVICE', 'description': 'Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person.', 'armGroupLabels': ['Biphasic followed by monophasic taVNS group', 'Monophasic followed by biphasic taVNS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Plumer Building', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Marlon Wong, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Marlon Wong', 'investigatorAffiliation': 'University of Miami'}}}}