Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-01-04 @ 4:31 PM
Study NCT ID:
NCT03327194
Status:
UNKNOWN
Last Update Posted:
2018-02-15
First Post:
2017-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006314', 'term': 'Hearing Loss, Conductive'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Monocentric prospective interventional single-subject design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal decibels gain measured by Audiological basic tests', 'timeFrame': 'Week 3'}, {'measure': 'Maximal decibels gain measured by speech reception threshold in quiet', 'timeFrame': 'Week 3'}], 'secondaryOutcomes': [{'measure': 'Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.', 'timeFrame': 'Day 0'}, {'measure': 'Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid', 'timeFrame': 'Day 0'}, {'measure': 'Change from baseline in Quality of Life measured by the SSQ12 questionnaire', 'timeFrame': 'week 3'}, {'measure': 'Change from baseline in Quality of Life measured by the SSQ12 questionnaire', 'timeFrame': 'month 3'}, {'measure': 'Change from baseline in Quality of Life measured by the SSQ12 questionnaire', 'timeFrame': 'month 6'}, {'measure': 'Change from baseline in Quality of Life measured by the SSQ12 questionnaire', 'timeFrame': 'month 12'}, {'measure': 'Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire', 'timeFrame': 'week 3'}, {'measure': 'Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire', 'timeFrame': 'month 3'}, {'measure': 'Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire', 'timeFrame': 'month 6'}, {'measure': 'Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire', 'timeFrame': 'month 12'}, {'measure': 'Number of subjects who discontinue study device utilization due to any AE or dissatisfaction', 'timeFrame': 'Year 1'}, {'measure': 'Average time of daily use of ADHEAR System', 'timeFrame': 'week 3', 'description': 'Adherence reported by patient on a diary card.'}, {'measure': 'Incidence of device-emergent adverse event.', 'timeFrame': 'Up to 1 year after start of study device utilization', 'description': 'Number of participants with device-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Conductive Hearing Loss', 'Single Sided Deafness']}, 'referencesModule': {'references': [{'pmid': '31689608', 'type': 'DERIVED', 'citation': 'Favoreel A, Heuninck E, Mansbach AL. Audiological benefit and subjective satisfaction of children with the ADHEAR audio processor and adhesive adapter. Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109729. doi: 10.1016/j.ijporl.2019.109729. Epub 2019 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'A hearing loss affects the quality of life and the natural development of children.\n\nThe new generation of hearing devices provides a huge number of options to them. These new hearing aids are often aesthetically acceptable, less invasive and user-friendly.\n\nThe ADHEAR Non-Implantable Bone Conduction Hearing System is connected directly to the skin with a special adhesive adapter. The device transmits the sound to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.\n\nThe objective of this study is to evaluate of the audiological benefit and subjective satisfaction of ADHEAR Audio Processor with Adhesive attachment in a group of children suffering from conductive hearing loss and/or single sided deafness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral and/or bilateral CHL (e. g. BC-thresholds \\<25dB HL)\n* Ability to perform all tests required for the study\n* Signed, and dated informed consent by parents and children where applicable\n\nExclusion Criteria:\n\n* intolerant of the materials\n* patient with a skin or scalp condition that may preclude the attachment of the adhesive plaster\n* fluctuation of hearing loss over a two year period of 15dB in either direction\n* retrocochlear, or central auditory disorders\n* any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures'}, 'identificationModule': {'nctId': 'NCT03327194', 'briefTitle': 'Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss', 'organization': {'class': 'OTHER', 'fullName': "Queen Fabiola Children's University Hospital"}, 'officialTitle': 'Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children', 'orgStudyIdInfo': {'id': 'P2017/ORL/ADHEAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADHEAR Audio processor', 'interventionNames': ['Device: ADHEAR Audio Processor']}], 'interventions': [{'name': 'ADHEAR Audio Processor', 'type': 'DEVICE', 'description': "ADHEAR Audio Processoris a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle.\n\nThe ADHEAR Audio Processor transmits sounds to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.\n\nADHEAR Audio Processor is classified as a Class lla medical device and ADHEAR Adhesive Adapter is classified as a Class I medical device.\n\nThe ADHEAR Audio Processor has the CE mark.", 'armGroupLabels': ['ADHEAR Audio processor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Amelia Favoreel', 'role': 'CONTACT', 'email': 'amelia.favoreel@huderf.be', 'phone': '0032 2 477 24 71'}], 'facility': 'Hôpital Universitaire Des Enfants Reine Fabiola', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Amélia Favoreel', 'role': 'CONTACT', 'email': 'amelia.favoreel@huderf.be', 'phone': '0032 2 477 24 71'}, {'name': 'Jenne Keyen', 'role': 'CONTACT', 'email': 'jenne.keyen@huderf.be', 'phone': '0032 2 477 24 71'}], 'overallOfficials': [{'name': 'Anne-Laure Mansbach, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen Fabiola Children's University Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen Fabiola Children's University Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'MED-EL Elektromedizinische Geräte GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}