Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT03514758
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2018-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065854', 'term': 'Spatial Navigation'}], 'ancestors': [{'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a group of normal-hearing volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-04-20', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Head movements measured with head tracker', 'timeFrame': '6 weeks', 'description': 'The participant starts the acoustic stimulus, tries to identify the direction of the stimulus as precise as possible and validates the final position. This is interpreted as reaction time with regard to spatial quality in seconds \\[s\\].'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ability, Spatial']}, 'referencesModule': {'references': [{'pmid': '15035561', 'type': 'BACKGROUND', 'citation': 'Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.'}, {'pmid': '17297794', 'type': 'BACKGROUND', 'citation': 'Choisel S, Wickelmaier F. Evaluation of multichannel reproduced sound: scaling auditory attributes underlying listener preference. J Acoust Soc Am. 2007 Jan;121(1):388-400. doi: 10.1121/1.2385043.'}, {'pmid': '23684420', 'type': 'BACKGROUND', 'citation': 'Mueller MF, Meisenbacher K, Lai WK, Dillier N. Sound localization with bilateral cochlear implants in noise: how much do head movements contribute to localization? Cochlear Implants Int. 2014 Jan;15(1):36-42. doi: 10.1179/1754762813Y.0000000040. Epub 2013 Nov 25.'}, {'pmid': '26328729', 'type': 'BACKGROUND', 'citation': 'Catic J, Santurette S, Dau T. The role of reverberation-related binaural cues in the externalization of speech. J Acoust Soc Am. 2015 Aug;138(2):1154-67. doi: 10.1121/1.4928132.'}, {'pmid': '27908072', 'type': 'BACKGROUND', 'citation': 'Simon LS, Zacharov N, Katz BF. Perceptual attributes for the comparison of head-related transfer functions. J Acoust Soc Am. 2016 Nov;140(5):3623. doi: 10.1121/1.4966115.'}]}, 'descriptionModule': {'briefSummary': 'A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strengths and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at the University Hospital of Zürich.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult normal hearing persons (minimum age: 18 years)\n* Healthy outer ear (without previous surgical procedures)\n* Ability to fill in a questionnaire conscientiously\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product\n* Limited mobility and not in the position to attend weekly appointments\n* Limited ability to describe listening impressions/experiences and the use of the hearing aid\n* Inability to produce a reliable hearing test result\n* Massively limited dexterity\n* Known psychological problems\n* Known central hearing disorders'}, 'identificationModule': {'nctId': 'NCT03514758', 'briefTitle': 'Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments', 'orgStudyIdInfo': {'id': '2017-02051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'normal hearing participants', 'description': 'normal hearing participants with and without hearing aids', 'interventionNames': ['Procedure: several virtual 3-D complex audio environments']}], 'interventions': [{'name': 'several virtual 3-D complex audio environments', 'type': 'PROCEDURE', 'description': 'The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.', 'armGroupLabels': ['normal hearing participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Norbert Dillier, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Swiss Commission for Technology and Innovation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}