Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-02 @ 1:44 AM
Study NCT ID:
NCT05067751
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asymmetrical Directionality With Bimodal Systems.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hearing loss will be assessed by using ecological momentary assessments to get a repeated sampling of their behaviors and experiences in real time.', 'timeFrame': '1 week', 'description': "Ecological momentary assessment will act as a digital diary, in real time, to understand subject's real life behaviors in their momentary environments."}], 'primaryOutcomes': [{'measure': 'Hearing loss assessed by the SSQ 12 hearing related questionnaire', 'timeFrame': '2 weeks', 'description': 'Speech Spatial and Qualities of hearing questionnaire is designed to measure of range of hearing disabilities across several domains. Specific attention is given to hearing speech in a host of competing contexts, and to the directional, distance and movement components of spatial hearing.'}], 'secondaryOutcomes': [{'measure': 'Hearing loss assessed by the AZ Bio sentence test in the presence of noise', 'timeFrame': '2 weeks', 'description': 'AZ Bio sentence in noise test comprised of 15 lists of 20 sentences each and is a measure of speech perception ability by individuals that mimics real life conditions with the presence of background noise.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. The aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.', 'detailedDescription': 'The primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an EMA tool. The aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects, male/female with diagnosed hearing loss that have been treated with Cochlear implants in one ear.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet the inclusion criteria described below to be eligible for this clinical investigation.\n\n1. Adults who are English speaking and aged 18 years and older.\n2. Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.\n3. New and experienced bimodal users (cochlear implant + hearing aid).\n4. Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.\n5. Individuals able to complete test measures as outlined in the informed consent and protocol.\n6. Individuals with access to a Smart Phone/device that is either iOS 7.0 or Android 4.0 and later who are willing to utilize their personal Smart Phone/device for participation in the trial.\n7. Individuals willing to use their personal email account for participation in the trial.\n\n \\-\n\nExclusion Criteria:\n\nSubjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.\n\n1. Individuals using sound processors in the Hybrid mode.\n2. Bilateral cochlear implant users.\n3. Unable or unwilling to comply with the requirements of the study as determined by the Investigator.\n4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n5. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT05067751', 'briefTitle': 'Asymmetrical Directionality With Bimodal Systems.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GN Hearing A/S'}, 'officialTitle': 'Evaluating the Effectiveness of Asymmetrical Directionality With Bimodal Systems.', 'orgStudyIdInfo': {'id': 'Parker'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hearing aid with directionality', 'type': 'DEVICE', 'description': 'Hearing directionality allows users the ability to focus on voices and other signals of interest, reducing background noises that are unimportant.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Megan E Quilter', 'role': 'CONTACT', 'email': 'mquilter@gnresound.com', 'phone': '13124157270'}, {'name': 'Bryan McDonald', 'role': 'CONTACT', 'email': 'bmcdonald@cochlear.com', 'phone': '303-472-4061'}], 'overallOfficials': [{'name': 'Megan Quilter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GN Hearing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GN Hearing A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}