Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05954520
Status:
WITHDRAWN
Last Update Posted:
2025-06-12
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Nonlinear Signal Processing Algorithms on Speech Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013060', 'term': 'Speech'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The student conducting this work took a job at another institution and is no longer continuing this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech understanding', 'timeFrame': '1-2 hours', 'description': 'Percent words correct will be measured'}], 'secondaryOutcomes': [{'measure': 'Preference', 'timeFrame': '15 minutes', 'description': 'Algorithm preference will be measured for each experimental condition'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['speech perception, hearing aids'], 'conditions': ['Speech', 'Hearing Loss, Sensorineural', 'Hearing Aids']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.', 'detailedDescription': "In this study, we are interested in how nonlinear algorithms influence speech perception.\n\nNonlinear algorithms are used within hearing aids and personal sound amplifiers to provide comfort to the listener. One of these algorithms provides amplification (gain) in a manner that depends on the level of the input sound.: Low-level sounds are amplified much more than high-level sounds. This type of amplification makes sounds more comfortable for listeners, but also distorts incoming sounds. To determine the effect of these algorithms on speech understanding, we will evaluate the following factors on speech perception, within the context of these algorithms:\n\n* The input Signal-to-Noise ratio (SNR) to the algorithm (3 different SNRs)\n* The type of background noise (20 people talking or 2 people talking)\n* Algorithm settings (slow and fast - whether changes to gain applied to fluctuating input sounds occurs quickly or slowly)\n\nTo address our questions, we are using a wearable processor (Tympan) that allows for real-time processing of audio signals. The Tympan itself contains microphones, a processor, and small earpieces that include speakers. A listener can wear the earpieces, like headphones, and listen to sounds processed by the Tympan in real time. The Tympan allows us access to the algorithms and to the sounds processed by the algorithms so that we cannot algorithm behavior to speech perception.\n\nOur study will complement existing work on speech perception and nonlinear algorithms, but our study will be the first to use a wearable processor in which the specific algorithm is known, tailored to an individual's hearing levels, and which allows for direct calculation of the output SNR. Most studies also have not measured speech perception, and this will be one of only a handful of studies with that objective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 65\n* Native speaker of English\n* Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.\n\nExclusion Criteria:\n\n* Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.\n* Subjects who younger than 18 or older than 65.\n* Subjects who are not native speakers of English.\n* Subjects with thresholds more than 70 dB HL at 2000 Hz and below'}, 'identificationModule': {'nctId': 'NCT05954520', 'briefTitle': 'Effects of Nonlinear Signal Processing Algorithms on Speech Perception', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Effects of Nonlinear Signal Processing Algorithms on Speech Perception', 'orgStudyIdInfo': {'id': '18675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perceptual measures', 'description': 'Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio)', 'interventionNames': ['Device: Tympan']}], 'interventions': [{'name': 'Tympan', 'type': 'DEVICE', 'description': 'Participants will wear a prototype hearing aid (called the Tympan)', 'armGroupLabels': ['Perceptual measures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47408', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Health Sciences Building', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jennifer J Lentz', 'investigatorAffiliation': 'Indiana University'}}}}