Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 9:52 PM
Study NCT ID:
NCT06400992
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Sky Automatic Technologies in Pediatrics
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': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech in noise perception (FraSimat)', 'timeFrame': '6 months', 'description': "Difference in the FraSimat score obtained with the Sky HS programmed in Omni versus the score obtained in AS Target. The scores vary from -15,0 to +15,0, the higher the score is, better is the patient's hearing comprehension."}], 'secondaryOutcomes': [{'measure': 'Speech in noise perception (FraSimat)', 'timeFrame': '6 months', 'description': "Difference in the FraSimat score obtained with the Sky HS programmed in AS Clinic versus the score obtained in Omni. The scores vary from -15,0 to +15,0, the higher the score is, better is the patient's hearing comprehension."}, {'measure': 'Speech in noise perception (FraSimat)', 'timeFrame': '6 months', 'description': "Difference in the FraSimat score obtained with the Sky HS programmed in AS Clinic versus the score obtained in AS Target. The scores vary from -15,0 to +15,0, the higher the score is, better is the patient's hearing comprehension."}, {'measure': 'Patient satisfaction - device', 'timeFrame': '6 months', 'description': "A patient questionnaire will be used to determine patient satisfaction with the devices. The scores vary from 0 to 10, the higher the score is better is the patient's satisfaction."}, {'measure': 'Patient satisfaction -listening', 'timeFrame': '6 months', 'description': "With the help of the audiologist, patients will discuss and rate listening quality in different listening situations. The scores vary from 1 to 5, the higher the score is better is the patient's listening quality."}, {'measure': 'Audiologist programming modifications', 'timeFrame': '6 months', 'description': "An audiologist questionnaire will be used to determine the programming modifications and decisions made by the audiologist for each individual patient. The questionnaire doesn't involve any scoring."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing Loss', 'cochlear implant', 'hearing aid', 'hearing device', 'hearing system', 'Simplified French Matrix Test', 'Noise block', 'background noise', 'target cochlear implant', 'pediatric cochlear implant processor'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance.', 'detailedDescription': "The ability to hear speech in noise is particularly important for children, as they are often in complex listening situations like classrooms or playgrounds. In children with hearing loss, the ability to understand speech in noise is further degraded not only by decreased audibility of speech sounds, but also additionally by the distortion spectral and temporal processing cues, and reduced binaural processing abilities. Cochlear implant manufacturers have introduced a number of technologies designed to improve speech recognition in background noise. Sound processing algorithms use a variety of strategies to facilitate listening in noise, and research has shown that these advances do lead to improved performance.\n\nAutoSense Sky OS 3.0 (AutoSense Sky OS, AS) is an automatic auditory scene classification system specifically designed for children's typical listening situations, like classrooms and playgrounds. This technology is available in the new Sky CI M90 (Sky CI), which is the latest generation of sound processor (SP) from Advanced Bionics, designed for children.\n\nThis algorithm is also available in the Sky Link M90 hearing aid (Sky Link). This means that bimodal patients, using one Sky Link and one Sky CI can benefit from AutoSense Sky OS in addition to children with two Sky CI. The combination of the two hearing devices (HD) tested in this research, whether it be two Sky CI or one Sky CI and one Sky Link, will be referred to as the Sky Hearing System (Sky HS).\n\nAs usual in standard care, children with Sky HS can have their hearing system programmed in three ways (at the discretion of the clinician):\n\n1. Omnidirectional mode, in which the AutoSense Sky OS is deactivated and no modifications are made by the clinician (no sound treatment)\n2. AS Target, in which the AutoSense Sky OS is active and programmed with the parameters suggested by the programming software (Target) and no modifications are made by the clinician\n3. AS clinic, in which the AutoSense Sky OS is active, and settings have been modified by the clinician (mixed setting).\n\nThe goal of this research is to compare speech in noise perception in each of those three possible programming conditions used in the standard care. The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 6 and 16 years of age at the time of inclusion\n* Use spoken French as their primary mode of communication\n* Ability to perform the Simplified French Matrix test in Noise\n* Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid\n* Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors\n* Obtain signed consent from legal guardian(s)\n* Be enrolled in a health insurance plan or eligible for coverage\n\nExclusion Criteria:\n\n* Severe neurological pathology identified prior to inclusion identified by MRI + /- neuro-pediatric workup\n* Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion\n* Family does not understand French'}, 'identificationModule': {'nctId': 'NCT06400992', 'acronym': 'SKY-MARVEL', 'briefTitle': 'Investigation of Sky Automatic Technologies in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Investigation of Sky Automatic Technologies in Pediatrics', 'orgStudyIdInfo': {'id': 'APHP230143'}, 'secondaryIdInfos': [{'id': '2023-A02351-44', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilaterally implanted patients', 'description': 'patient with two cochlear implant in each ear', 'interventionNames': ['Device: Cochlear implant processor Sky CITM M90 (CI-5295)', 'Device: Hearing Aid, including sound processor Phonak: Sky Link M90', 'Diagnostic Test: French simplified matrix test (FraSimat)', 'Behavioral: Audiologist Fitting Questionnaire', 'Behavioral: Patient Satisfaction Questionnaire', 'Behavioral: AutoSens Feedback Discussion Form']}, {'type': 'EXPERIMENTAL', 'label': 'Bimodal patients', 'description': 'patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear', 'interventionNames': ['Device: Hearing Aid, including sound processor Phonak: Sky Link M90', 'Diagnostic Test: French simplified matrix test (FraSimat)', 'Behavioral: Audiologist Fitting Questionnaire', 'Behavioral: Patient Satisfaction Questionnaire', 'Behavioral: AutoSens Feedback Discussion Form']}], 'interventions': [{'name': 'Cochlear implant processor Sky CITM M90 (CI-5295)', 'type': 'DEVICE', 'description': 'The Sky CI available to included patients (no procedures added) offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion:\n\n1. Omnidirectional mode : no sound treatment\n2. AS Target : Autosense is active and no modifications are made by clinician\n3. AS Clinique : Autosense is active and modified by the clinician', 'armGroupLabels': ['Bilaterally implanted patients']}, {'name': 'Hearing Aid, including sound processor Phonak: Sky Link M90', 'type': 'DEVICE', 'description': 'The device is fitting and programmed for home especially for the purpose research at inclusion. The Clinical map parameters will be verified according to clinical routine.\n\nThe Sky Link offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion:\n\n1. Omnidirectional mode : no sound treatment\n2. AS Target : Autosense is active and no modifications are made by clinician\n3. AS Clinique : Autosense is active and modified by the clinician', 'armGroupLabels': ['Bilaterally implanted patients', 'Bimodal patients']}, {'name': 'French simplified matrix test (FraSimat)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The FraSimat speech in noise test will be tested, 6 months before inclusion in the three different fitting configurations: omni, AS clinic, AS Target. The speech will be presented from the front, noise from 180°. Noise will be presented at a fixed level of 65 dB SPL while the speech signal will be adapted to find the 50% speech reception threshold (SRT).', 'armGroupLabels': ['Bilaterally implanted patients', 'Bimodal patients']}, {'name': 'Audiologist Fitting Questionnaire', 'type': 'BEHAVIORAL', 'description': 'After the fitting of Hearing Aid at inclusion, the audiologist will complete a questionnaire describing the fitting and justifying fitting decisions and will collect the demographic information', 'armGroupLabels': ['Bilaterally implanted patients', 'Bimodal patients']}, {'name': 'Patient Satisfaction Questionnaire', 'type': 'BEHAVIORAL', 'description': 'The patient will be giving a Patient satisfaction Questionnaire, with questions regarding device and accessory use. The audiologist will go over the instructions for filling out the questionnaire at inclusion. Patients will be asked to complete the questionnaire and return it at the next visit, 6 months after inclusion.', 'armGroupLabels': ['Bilaterally implanted patients', 'Bimodal patients']}, {'name': 'AutoSens Feedback Discussion Form', 'type': 'BEHAVIORAL', 'description': '6 months after inclusion and fitting, the audiologist discusses the use of AS clinic with the subject and completes the AS questionnaire (questionnaire on the experience of using the processor in different listening situations).', 'armGroupLabels': ['Bilaterally implanted patients', 'Bimodal patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Melissa MACSKILL', 'role': 'CONTACT', 'email': 'melissa.macaskill-ext@aphp.fr', 'phone': '01 87 89 29 14', 'phoneExt': '+33'}, {'name': 'Nathalie LOUNDON, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") at the Necker-Enfants Malades hospital (AP-HP).', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Nathalie LOUNDON, MD, PhD', 'role': 'CONTACT', 'email': 'natalie.loundon@aphp.fr', 'phone': '01 71 39 67 82', 'phoneExt': '+33'}, {'name': 'Gael PLASTOW', 'role': 'CONTACT', 'email': 'gael.plastow@aphp.fr', 'phone': '0144381711', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Nathalie LOUNDON, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Advanced Bionics AG', 'class': 'INDUSTRY'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}