Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-29 @ 12:41 PM
Study NCT ID:
NCT06317493
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080762', 'term': 'Stimuli Responsive Polymers'}], 'ancestors': [{'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D000080745', 'term': 'Smart Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity index of pupillometry test', 'timeFrame': 'Within 30 minutes from enrolment', 'description': 'The peak and the average pupil dilation will be defined for each trial and the difference between trials below and above the threshold will be defined within each block. The difference between the trials with and without audible stimuli will be assessed using the multiple corrected t- tests. The sensitivity index of the pupillometric exam compared to the audiometry results will be computed for the whole group using a signal detection analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pupillometry', 'Hearing threshold', 'Pediatric cochlear implants'], 'conditions': ['Hearing Impaired Children']}, 'descriptionModule': {'briefSummary': 'The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '4 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with and without hearing impairment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal or corrected-to-normal vision\n* No history of relevant neurological or psychiatric concomitant disease\n* Age: 4-36 months\n* At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects)\n\nExclusion Criteria:\n\n* Developmental disorders\n* Unwillingness of the subject to participate further'}, 'identificationModule': {'nctId': 'NCT06317493', 'briefTitle': 'Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment', 'orgStudyIdInfo': {'id': 'RC 15/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hearing threshold without aids', 'description': 'Case group with hearing impairment (HI) (hearing threshold \\>35 dB) without aids', 'interventionNames': ['Other: Stimuli']}, {'label': 'Hearing threshold with cochlear implant', 'description': 'Case group with hearing threshold corrected with cochlear implant (CI)', 'interventionNames': ['Other: Stimuli']}, {'label': 'Hearing threshold with aids', 'description': 'Case group with hearing threshold corrected with hearing aids', 'interventionNames': ['Other: Stimuli']}, {'label': 'Control group', 'description': 'Control group of normally hearing age-matched children', 'interventionNames': ['Other: Stimuli']}], 'interventions': [{'name': 'Stimuli', 'type': 'OTHER', 'description': 'Auditory Stimuli: Pure tone bursts with main frequencies of 500, 1000, 2000, and 4000 Hz. Each tone will be presented at 10dB above the estimated individual threshold per frequency and compared to the responses to trials without auditory stimuli. Auditory stimulus duration: 25ms, there is 200ms baseline period before each trial, and 2000 ms interstimulus interval.\n\nVisual stimuli: an animated movie adapted for the age and controlled for luminosity levels.\n\nPupil data will be collected through a "Tobii PRO" screen-based eye-tracker that measures eye-movements and pupil dilation using the infrared light cameras.', 'armGroupLabels': ['Control group', 'Hearing threshold with aids', 'Hearing threshold with cochlear implant', 'Hearing threshold without aids']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Padua', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'UOC Otorinolaringoiatria', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Perugia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Università degli Studi di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Torino', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Martini', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '34137', 'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Eva Orzan, MD', 'role': 'CONTACT', 'email': 'eva.orzan@burlo.trieste.it', 'phone': '+39.040.3785.537'}, {'name': 'Amanda Saksida', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Ljubljana', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Slovenia', 'facility': 'Univeristy Medical Center', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Eva Orzan, MD', 'role': 'CONTACT', 'email': 'eva.orzan@burlo.trieste.it', 'phone': '+39.040.3785.537'}, {'name': 'Amanda Saksida', 'role': 'CONTACT', 'email': 'eva.orzan@burlo.trieste.it', 'phone': '+39.040.3785.537'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}