Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-04 @ 5:50 PM
Study NCT ID:
NCT02109757
Status:
UNKNOWN
Last Update Posted:
2014-04-10
First Post:
2014-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hearing Protection Fit Testing Program
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-07', 'studyFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.', 'timeFrame': '6 mos after intial subject visit', 'description': 'The experimental group will show an increase, larger than the control group, in the amount of personal attenuation rating measurement shown by the software program as a result of software intervention used before and after education at the initial and follow-up visits.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hearing conservation', 'Personal attenuation rating', 'earplug'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force (USAF) employees. Currently, Public Health provides informal, subjective training to employees; this practice may be altered by the results of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. Subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction.\n\nExclusion Criteria:\n\n* Not enrolled in the hearing conservation program. Not using in-the-ear hearing protection device on a regular basis. Ear canals containing cerumen, infection, or other obstructions.'}, 'identificationModule': {'nctId': 'NCT02109757', 'briefTitle': 'Evaluation of Hearing Protection Fit Testing Program', 'organization': {'class': 'FED', 'fullName': 'United States Air Force'}, 'officialTitle': 'Evaluation of Hearing Protection Fit Testing Program', 'orgStudyIdInfo': {'id': 'FWR20130114H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Software intervention and education', 'description': 'This group will receive software intervention and education before and after receiving one-on-one education, thus showing if benefit or effect occurs simply due to having the software input before receiving education.', 'interventionNames': ['Other: Software intervention and education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education only', 'description': 'This group will not receive software intervention prior to and after one-on-one education, only afterwards.', 'interventionNames': ['Other: Education only']}], 'interventions': [{'name': 'Software intervention and education', 'type': 'OTHER', 'description': 'Personal attenuation rating measurements will be taken before and after educating the patient using software program', 'armGroupLabels': ['Software intervention and education']}, {'name': 'Education only', 'type': 'OTHER', 'armGroupLabels': ['Education only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Elemendorf Air Force Base', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shannon Hunt, Au.D.', 'role': 'CONTACT', 'email': 'shannon.hunt.3@us.af.mil', 'phone': '907-580-5804'}, {'name': 'Shannon Hunt, Au.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Williams, Au.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Elmendorf Air Force Base'}, {'zip': '45433', 'city': 'Dayton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Quintin A Hecht, Au.D.', 'role': 'CONTACT', 'email': 'quintin.hecht.1@us.af.mil', 'phone': '937-938-3201'}, {'name': 'Quintin A Hecht, Au.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elizabeth A McKenna, Au.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'April Taylor, Au.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Malisha Martukovich, Au.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthew Williams, Au.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katie Tastad, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christina Waldrop, Associates', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michelle LeMond, Associates', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wright-Patterson Air Force Base', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}], 'overallOfficials': [{'name': 'Quintin A Hecht, Au.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Air Force School of Aerospace Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Air Force', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hearing Conservation Program Manager, Doctor of Audiology', 'investigatorFullName': 'Quintin Hecht', 'investigatorAffiliation': 'United States Air Force'}}}}