Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-01 @ 6:03 PM
Study NCT ID:
NCT05561335
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2022-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preference Comparisons for Algorithms to Hear Speech
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall preference for a specific microphone setting/configuration', 'timeFrame': '20 minutes', 'description': "Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')"}], 'secondaryOutcomes': [{'measure': 'Rating of awareness of background noise', 'timeFrame': '20 minutes', 'description': "Scale from 0-100 with descriptors ('not at all' to 'extremely aware')"}, {'measure': 'Rating of Listening effort', 'timeFrame': '20 minutes', 'description': "Scale from 1 - 7 with descriptors ('not at all' to 'very')"}, {'measure': 'Rating of annoyance of artefacts', 'timeFrame': '20 minutes', 'description': "Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.', 'detailedDescription': "People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.\n\nThis study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.\n\nOf particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects fulfilling all of the following inclusion criteria are eligible for the investigation:\n\n* Including adults with sensorineural mild to moderate-severe hearing loss\n* hearing aid experience (greater than 6 months)\n* who are able to complete the task in English.\n* Language: Can speak and understand English Fluently\n\nHearing loss within the fitting ranges of the investigational products.\n\n* Healthy outer ear.\n* Ability to understand instructions.\n* Ability to describe listening experiences.\n* Ability to fill out questionnaires.\n* Informed consent as documented by signature.\n\nExclusion Criteria:\n\n\\- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:\n\n* Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).\n* Limited mobility and not able to attend to appointments or not able to go in a car.\n* Reported symptoms of vertigo and dizziness by subject.\n* Severe Tinnitus'}, 'identificationModule': {'nctId': 'NCT05561335', 'briefTitle': 'Preference Comparisons for Algorithms to Hear Speech', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference', 'orgStudyIdInfo': {'id': '5251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing Aid use for listening to speech in a common difficult situation', 'description': 'The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.', 'interventionNames': ['Device: hearing aid -novel program', 'Device: hearing aid - standard program']}], 'interventions': [{'name': 'hearing aid -novel program', 'type': 'DEVICE', 'description': 'novel microphone configuration', 'armGroupLabels': ['Hearing Aid use for listening to speech in a common difficult situation']}, {'name': 'hearing aid - standard program', 'type': 'DEVICE', 'description': 'standard microphone configuration', 'armGroupLabels': ['Hearing Aid use for listening to speech in a common difficult situation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6G 1G9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paula Folkeard, AuD', 'role': 'CONTACT', 'email': 'folkeard@nca.uwo.ca', 'phone': '519-661-2111', 'phoneExt': '88936'}], 'facility': 'Western University', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Don Hayes, PhD', 'role': 'CONTACT', 'email': 'don.hayes@unitron.com', 'phone': '519 500 3618'}], 'overallOfficials': [{'name': 'Susan Scollie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University (aka The University of Western Ontario)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Western University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}