Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-01 @ 12:17 PM
Study NCT ID:
NCT02946567
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Game to Improve Hearing Health Care Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge, Attitudes, and Intended Behavior Questionnaire about hearing health care', 'timeFrame': '9 weeks', 'description': 'This instrument has been used to evaluate the effectiveness of past hearing loss prevention programs funded by the National Institute of Health. It contains questions on knowledge, attitudes, and intended behavior related to hearing health care. Although there are questions in different domains, the instrument consolidates the overall perception of participant on hearing health care.'}]}, 'conditionsModule': {'conditions': ['Focus of the Study is to Promote Healthy Hearing']}, 'descriptionModule': {'briefSummary': 'The investigators are studying the educational potential of games, with the goal of developing a game to improve learning and promote healthy hearing behaviors.\n\nThe project is looking for adolescents and young adults that play games to share their experience and learning from playing games.\n\nThe investigators ask participants to fill out an enrollment form/informed consent, complete surveys on healthy hearing habits, and play a game provided by the project.\n\nThis projects aims the development and evaluation of a game to educate teenagers and young adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy hearing behaviors with the potential to improve hearing health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants have to be between the ages of 13 and 20 years of age (either gender).\n* Participants who are between the ages of 13 and 17 years of age must have a willing and able parent or legal guardian who permits them to participate.\n* Participants must have Internet access, an email address (or be able to use parent's/legal guardian's email address), and agree to play a game (random assignment to a group with a different game).\n\nExclusion Criteria:\n\n* Participants will be excluded if they are cognitively impaired, have any serious medical problem that may interfere with their ability to engage with the online game.\n* Those who are not able to read/follow written instructions and individuals with an excessive addiction to games will be excluded."}, 'identificationModule': {'nctId': 'NCT02946567', 'acronym': 'NoisyCity', 'briefTitle': 'Game to Improve Hearing Health Care Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Photozig, Inc.'}, 'officialTitle': 'Game to Improve Hearing Health Care Outcomes', 'orgStudyIdInfo': {'id': 'Pz-A105a'}, 'secondaryIdInfos': [{'id': 'R44DC013114', 'link': 'https://reporter.nih.gov/quickSearch/R44DC013114', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noisy City', 'description': 'Participant will play the Noisy City game developed by this project.', 'interventionNames': ['Other: Noisy City information about hearing health care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participant will play a generic game.', 'interventionNames': ['Other: Generic Game']}], 'interventions': [{'name': 'Noisy City information about hearing health care', 'type': 'OTHER', 'description': 'Participants will play the game Noisy City, which contains information about hearing health care.', 'armGroupLabels': ['Noisy City']}, {'name': 'Generic Game', 'type': 'OTHER', 'description': 'Participants will play a generic game without any particular information about hearing health care.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94035-0128', 'city': 'Moffett Field', 'state': 'California', 'country': 'United States', 'facility': 'Photozig, Inc.'}], 'overallOfficials': [{'name': 'Bruno Kajiyama, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Photozig, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Photozig, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Bruno Kajiyama', 'investigatorAffiliation': 'Photozig, Inc.'}}}}