Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 3:10 AM
Study NCT ID:
NCT07074769
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2025-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss
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': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unaided and Aided speech in noise Matrix test', 'timeFrame': '1 hour', 'description': 'Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR'}, {'measure': 'Unaided and Aided Connected speech-in-noise tests', 'timeFrame': '1 hour', 'description': 'Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated'}], 'secondaryOutcomes': [{'measure': 'Unaided vs Aided Ratings of Listening Effort', 'timeFrame': '30 minutes', 'description': 'Evaluation of the listening effort with and without device trough questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.', 'detailedDescription': "This primary objective is to evaluate whether the device improves speech recognition in noise compared to the clinically relevant comparison condition of no treatment (unaided) for adults with mild to moderate hearing loss. The primary outcome will be measured using a clinically available test of speech recognition in noise that uses adaptive bracketing of signal to noise ratio (the Matrix test). The secondary outcome will also assess speech recognition in babble at ecologically valid fixed signal to babble ratios (The Connected Speech Test). Tertiary outcomes will examine device users' ratings of listening effort in noise with and without the device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* symmetrical bilateral mild to moderate sensorineural hearing loss\n* native speakers of English.\n\nExclusion Criteria:\n\n* Children\n* those without hearing loss\n* those without symmetrical bilateral mild to moderate sensorineural hearing loss\n* those who do not wish to wear the test device instead of their own spectacles during the in-lab procedure\n* those who are not native speakers of English\n* those who have pacemakers, other implantable devices, or insulin pumps'}, 'identificationModule': {'nctId': 'NCT07074769', 'briefTitle': 'Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luxottica Group S.p.A.'}, 'officialTitle': 'In-Lab Evaluation of A Hearing Aid Housed in Ophthalmic Spectacles for Mild to Moderate Hearing Loss', 'orgStudyIdInfo': {'id': 'Protocol version 4 9.6.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A prospective in-lab within-subjects design with repeated measures', 'description': "Test of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device.", 'interventionNames': ['Device: Evaluation of speech-in-noise intelligibility and listening effort']}], 'interventions': [{'name': 'Evaluation of speech-in-noise intelligibility and listening effort', 'type': 'DEVICE', 'description': 'The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire', 'armGroupLabels': ['A prospective in-lab within-subjects design with repeated measures']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6G 1G9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Western University', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luxottica Group S.p.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}