Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT06022367
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2022-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Activation Technique in cVEMPs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-31', 'releaseDate': '2024-02-14'}, {'resetDate': '2025-07-17', 'releaseDate': '2025-07-01'}], 'estimatedResultsFirstSubmitDate': '2024-02-14'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2022-11-23', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cVEMP signal quality', 'timeFrame': 'During single 1.5 hour appointment', 'description': 'Ratio of cVEMP signal power to background noise power'}], 'secondaryOutcomes': [{'measure': 'cVEMP signal amplitude', 'timeFrame': 'During single 1.5 hour appointment', 'description': 'P1-N1 amplitude measured from the P1 to N1 peaks'}, {'measure': 'Activation technique tolerability rating', 'timeFrame': 'During single 1.5 hour appointment', 'description': 'Participant reported tolerability will be scored on a four-point LIKERT scale ranging from 1 (highly intolerable) to 4 (highly tolerable)'}, {'measure': 'Activation technique tolerability subjective feedback', 'timeFrame': 'During single 1.5 hour appointment', 'description': 'Participant reported concerns shared through a post-test questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Activation Technique in cVEMP Testing']}, 'descriptionModule': {'briefSummary': 'This study will investigate two different techniques used for eliciting sternocleidomastoid (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are used clinically to assess the function of structures within the vestibular system.\n\nThe British Society of Audiology (BSA) guidelines recommend the head turn and head raise techniques as effective methods for eliciting SCM contraction. However, they do not recommend which technique to employ, leaving that to the discretion of the clinician. The purpose of this study is to determine which activation technique to recommend in the local standard operating procedure on cVEMP testing developed by the Audiology and Vestibular Function Testing service based at the Royal Liverpool University Hospital.\n\nHealthy volunteers will be recruited to the study. The study will be conducted at the Royal Liverpool University Hospital, Liverpool, UK.\n\nThe participants will each be invited to attend one appointment in which they will undergo cVEMP testing, performed using each activation technique in turn. After testing the participants will be asked to complete a questionnaire in which they will comment on their experience of performing each technique and assign each a tolerability rating.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Able (in the Investigators opinion) and willing to comply with all study requirements.\n* Male, female or non-binary, aged 18-60 years old.\n\nExclusion Criteria:\n\n* Pain, sore areas, broken skin at the sites of contact with skin electrodes\n* Devices, e.g. cochlear implants, which may cause electrical interference\n\nExclusion criteria to cVEMP procedure :\n\n* Conductive hearing loss of middle ear origin\n* Sensitivity to sounds e.g. tinnitus, hyperacusis etc.\n* Cervical spine problems\n\nExclusion criteria to tympanometry procedure :\n\n* Occlusion of the external auditory canal\n* Otorrhoea\n* Otalgia\n* Excessive wax\n* Within two months of ear surgery'}, 'identificationModule': {'nctId': 'NCT06022367', 'acronym': 'ACTIVE', 'briefTitle': 'Activation Technique in cVEMPs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Liverpool University Hospitals NHS Foundation Trust'}, 'officialTitle': 'An Investigation Into the Effect of the Head Raise and Head Turn Activation Techniques on Quality of Elicited Cervical Vestibular Evoked Myogenic Potentials (cVEMPs)', 'orgStudyIdInfo': {'id': 'LHS0016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raise-Turn Sequence', 'description': 'Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.', 'interventionNames': ['Diagnostic Test: Head Turn Activation Technique', 'Diagnostic Test: Head Raise Activation Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Turn-Raise Sequence', 'description': 'Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.', 'interventionNames': ['Diagnostic Test: Head Turn Activation Technique', 'Diagnostic Test: Head Raise Activation Technique']}], 'interventions': [{'name': 'Head Turn Activation Technique', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participant sat upright with head turned to the side through 45 degrees. They are presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.', 'armGroupLabels': ['Raise-Turn Sequence', 'Turn-Raise Sequence']}, {'name': 'Head Raise Activation Technique', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participant assumes caloric test position (30 degrees from horizontal) with head raised. Participant is presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.', 'armGroupLabels': ['Raise-Turn Sequence', 'Turn-Raise Sequence']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool University Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-14', 'type': 'RELEASE'}, {'date': '2024-07-31', 'type': 'RESET'}, {'date': '2025-07-01', 'type': 'RELEASE'}, {'date': '2025-07-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Liverpool University Hospitals NHS Foundation Trust'}}}}