Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT06161857
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Frequency ABR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-09', 'releaseDate': '2025-04-24'}, {'resetDate': '2025-06-16', 'releaseDate': '2025-06-02'}, {'resetDate': '2025-07-15', 'releaseDate': '2025-06-26'}], 'estimatedResultsFirstSubmitDate': '2025-04-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006316', 'term': 'Hearing Loss, High-Frequency'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between ABR and PTA thresholds', 'timeFrame': 'through study completion, 4-5 months', 'description': 'Compare ABR thresholds to PTA thresholds at 6 and 8 kHz in normal hearing adults and adults with sensorineural hearing loss.'}], 'secondaryOutcomes': [{'measure': 'Effect of participants hearing level on ABR-PTA threshold differences', 'timeFrame': 'through study completion, 4-5 months', 'description': 'Analyse the effect of hearing level on ABR-PTA threshold differences.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, High-Frequency']}, 'descriptionModule': {'briefSummary': "This study is looking at a method called 'ABR', which measures the electrical activity in the brain (brain waves) when we hear sounds. This study will look at the electrical activity in participants brains in response to high-pitched sounds. First, the investigators will find the quietest sounds the participants can hear. Then the investigators will use 'ABR' to measure the quietest sounds that trigger electrical activity in participants brains'. This is to find out if there is a difference between the quietest sounds participants can hear, and the quietest sounds that trigger these brain waves. We are also interested in finding out if having a hearing loss affects this.", 'detailedDescription': "The most common way of measuring how good someone's hearing is, is to play them sounds at different levels and ask them to respond when they can hear it, for example, by pressing a button when they hear a sound. However, some people such as young children and people with learning disabilities can't do this. So, we may use the ABR technique instead. However, there are usually differences between ABR thresholds (the quietest level of sound needed to trigger an electrical response in the brain) and behavioural hearing level thresholds (the quietest level sound is perceived). If we know what this difference usually is, we can use ABR to work out how good someone's hearing is. We can already do this for most of the important pitches (aka frequencies) of sound, as typically experienced in the muffled sound in telephones. But we do not know the difference between ABR and behavioural thresholds for high-pitched sounds that help make hearing crisper. So, that is what this study is trying to find out.\n\nTo do this we need people with different hearing levels to participate in our study. Including people with normal hearing and people with a hearing loss. We aim to recruit nearly 40 people in total with a range of different hearing levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study needs a range of participants with different hearing levels.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is able and willing to give informed consent.\n* Participant is over 18.\n* Hearing in the test ear of ≤90dBSPL at 6 kHz and 8 kHz in PTA\n* Able and willing to perform PTA reliably.\n* Able and willing to sit still comfortably for the duration of an ABR.\n\nExclusion Criteria:\n\n* Any conductive element to hearing loss (air-bone gap on PTA of \\>10dB).\n* Occluding wax, TM perforations or ear infections (on otoscopy)\n* CI or BAHA user\n* Abnormal outer of middle ear'}, 'identificationModule': {'nctId': 'NCT06161857', 'briefTitle': 'High Frequency ABR', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cardiff and Vale University Health Board'}, 'officialTitle': 'Auditory Brainstem Response Thresholds at 6 and 8KHz in Adults With Normal Hearing and Sensorineural Hearing Loss', 'orgStudyIdInfo': {'id': '8537'}, 'secondaryIdInfos': [{'id': '32889', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Hearing Group', 'description': 'Participants with hearing levels of 20dBHL or better at 6 and 8kHz frequencies of sound', 'interventionNames': ['Other: No intervention']}, {'label': 'Mild Hearing Loss Group', 'description': 'Participants with hearing levels of 25-40dBHL at 6 and 8kHz frequencies of sound', 'interventionNames': ['Other: No intervention']}, {'label': 'Moderate Hearing Loss Group', 'description': 'Participants with hearing levels of 45-70dBHL at 6 and 8kHz frequencies of sound', 'interventionNames': ['Other: No intervention']}, {'label': 'Severe Hearing Loss Group', 'description': 'Participants with hearing levels of 75- 90dBHL at 6 and 8kHz frequencies of sound', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There is no intervention this is an observational study to develop a diagnostic test', 'armGroupLabels': ['Mild Hearing Loss Group', 'Moderate Hearing Loss Group', 'Normal Hearing Group', 'Severe Hearing Loss Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cardiff', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Research and Development', 'role': 'CONTACT'}], 'facility': 'Cardiff and Value University Health Board', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'centralContacts': [{'name': 'Eirwin Chief Investigator', 'role': 'CONTACT', 'email': 'Eirwen.jones@wales.nhs.uk', 'phone': '02921 843179'}, {'name': 'Emma Principle Investigator', 'role': 'CONTACT', 'email': 'kelly.choi-2@postgrad.manchester.ac.uk', 'phone': '07594192052'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff and Vale University Health Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-04-24', 'type': 'RELEASE'}, {'date': '2025-05-09', 'type': 'RESET'}, {'date': '2025-06-02', 'type': 'RELEASE'}, {'date': '2025-06-16', 'type': 'RESET'}, {'date': '2025-06-26', 'type': 'RELEASE'}, {'date': '2025-07-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cardiff and Vale University Health Board'}}}}