Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 10:54 PM
Study NCT ID:
NCT07116135
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech Understanding and Listening Effort Benefits of Hearing Instruments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006312', 'term': 'Hearing Loss, Bilateral'}], 'ancestors': [{'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'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The participant will not know which condition they are being tested in, but all participants will be given the same intervention and not blinded to the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hearing Instrument Device Preference Questionnaire', 'timeFrame': 'Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.', 'description': 'Participants are asked to subjectively rate elements of sound quality and overall preference of the devices under test following standardized presentation of speech-in-noise stimuli in the lab environment.'}], 'primaryOutcomes': [{'measure': 'Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task', 'timeFrame': 'Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.', 'description': 'During the CRM task (Bolia et al., 2000), participants are presented with a phrase detailing the following identifiers: target, color, and digit.\n\nThey must listen for a target name and respond with the corresponding color and digit. Speech intelligibility performance is assessed based on accuracy, or percent correct across all trials conducted in a given condition.'}], 'secondaryOutcomes': [{'measure': 'Listening Effort as assessed by the Adaptive Categorical Listening Effort Scaling (ACALES)', 'timeFrame': 'Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.', 'description': 'The ACALES is an adaptive measure of listening effort where the target and interfering background signals are adapted according to participant feedback. Following the target presentation, participants rate listening effort on a 14-point scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss, Bilateral']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to investigate the benefits of hearing instrument use in adults with hearing loss. The main questions it aims to answer are:\n\nDoes hearing instrument use improve speech understanding and listening effort amount people with hearing loss? Researchers will compare varying models of hearing instruments to see how speech understanding and listening effort are impacted.\n\nParticipants will be asked to wearing varying hearing instruments and participate in lab-based activities to evaluate their speech understanding, listening effort, and subjective preference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18-95 years\n* N3 or N4 hearing loss\n* Experienced hearing aid user\n* English fluency\n* Cognitively able to complete complex listening tasks\n\nExclusion Criteria:\n\n* Outside of specified age range\n* Vulnerable populations\n* Hearing within normal limits or otherwise not appropriate for hearing instruments under study\n* Inability to read, write, or speak English\n* Inability to complete complex listening tasks'}, 'identificationModule': {'nctId': 'NCT07116135', 'briefTitle': 'Speech Understanding and Listening Effort Benefits of Hearing Instruments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Speech Understanding and Listening Effort Benefits of Infinio Sphere', 'orgStudyIdInfo': {'id': 'SRF-22934 STUDY7873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing instrument users', 'description': 'Individuals with hearing impairment will be fit with three different models of hearing instruments. They will all be fit with the same hearing instruments, although they will not be aware which model they are using at the time of testing.', 'interventionNames': ['Device: hearing instruments']}], 'interventions': [{'name': 'hearing instruments', 'type': 'DEVICE', 'otherNames': ['hearing aids'], 'description': 'Participants will be fit with three different models of hearing instruments.', 'armGroupLabels': ['Hearing instrument users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'ant-lab@usf.edu', 'phone': '813-974-4148'}], 'facility': 'University of South Florida Auditory Neurosciences & Technology Lab', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'ant-lab@usf.edu', 'phone': '813-974-4148'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of South Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}