Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-26 @ 8:41 PM
Study NCT ID:
NCT04696835
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
fNIRS in Pediatric Hearing Aids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001302', 'term': 'Audiometry, Speech'}], 'ancestors': [{'id': 'D001299', 'term': 'Audiometry'}, {'id': 'D006320', 'term': 'Hearing Tests'}, {'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenated haemoglobin concentration (HbO)', 'timeFrame': 'Baseline (at inclusion)'}], 'secondaryOutcomes': [{'measure': 'Deoxygenated haemoglobin concentration (HbR)', 'timeFrame': 'Baseline (at inclusion)'}, {'measure': 'HbO Concentration', 'timeFrame': 'At 3 months, 6 months, 12 months and 24 months', 'description': 'Evolution of the variation in HbO concentration in the group of infants fitted with a device.'}, {'measure': 'HbR Concentration', 'timeFrame': 'At 3 months, 6 months, 12 months and 24 months', 'description': 'Evolution of the variation in HbR concentration in the group of infants fitted with a device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NIRS', 'hearing aid', 'pediatrics', 'cochlear implant', 'rehabilitation', 'neuroimaging'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants.\n\nHemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS.\n\nThe use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group A: Infants and toddlers 3-18 months of age who are normal hearing.\n* Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional.\n* Socially insured subject\n* Parents or guardians who have given their consent to participate in the study\n\nExclusion Criteria:\n\n* Medical condition that does not allow for research compliance.'}, 'identificationModule': {'nctId': 'NCT04696835', 'acronym': 'FNIRS', 'briefTitle': 'fNIRS in Pediatric Hearing Aids', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)', 'orgStudyIdInfo': {'id': '2018_73'}, 'secondaryIdInfos': [{'id': '2019-A02517-50', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'children with hearing aids', 'interventionNames': ['Diagnostic Test: speech audiometry']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'interventionNames': ['Diagnostic Test: speech audiometry']}], 'interventions': [{'name': 'speech audiometry', 'type': 'DIAGNOSTIC_TEST', 'description': '65dB, 55dB or 75dB SPL speech audiometry', 'armGroupLabels': ['children with hearing aids', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}], 'facility': 'Hopital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Christophe VINCENT, PU-PH', 'role': 'CONTACT', 'email': 'christophe.vincent@chru-lille.Fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Christophe VINCENT, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation William Demant', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}