Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-02 @ 4:00 AM
Study NCT ID:
NCT04921267
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2020-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of Training on Effortful Listening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Participant doesn't know what condition they are in."}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups. One group is trained to listening through simulated hearing protection. The other receives no such training.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pretest EEG alpha power', 'timeFrame': 'one day before training', 'description': 'power in the alpha-band'}, {'measure': 'posttest EEG alpha power', 'timeFrame': 'one day after training', 'description': 'power in the alpha-band'}, {'measure': 'pretest accuracy', 'timeFrame': 'one day before training', 'description': 'proportion correct for identifying speech'}, {'measure': 'posttest accuracy', 'timeFrame': 'one day after training', 'description': 'proportion correct for identifying speech'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Training Group']}, 'descriptionModule': {'briefSummary': 'Human listeners will hear speech masked by single-talker speech before and after auditory training.', 'detailedDescription': 'Human listeners will hear speech masked by single-talker speech before and after auditory training. Training-related changes in EEG dynamics and behavioral measures of accuracy and effort will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal hearing\n\nExclusion Criteria:\n\n* hearing loss'}, 'identificationModule': {'nctId': 'NCT04921267', 'briefTitle': 'Impacts of Training on Effortful Listening', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Impacts of Training on Effortful Listening', 'orgStudyIdInfo': {'id': 'IRB9406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trained group', 'description': 'group receives training with sounds that correspond to simulated hearing protection', 'interventionNames': ['Behavioral: training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'group receives no training'}], 'interventions': [{'name': 'training', 'type': 'BEHAVIORAL', 'description': 'training with filtered speech', 'armGroupLabels': ['trained group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66506', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas State University', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'overallOfficials': [{'name': 'Matthew Wisniewski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew Wisniewski', 'investigatorAffiliation': 'Kansas State University'}}}}