Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT05848804
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Screener Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Thresholds', 'timeFrame': '1 Year', 'description': 'The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We aim to perform an in-office hearing test and compare the thresholds with those measured from the iPad at a distance of 11ft with an SPL (dBA) meter. Comparing hearing test results between the LHHS and the results of a lab grade audiogram.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Screener']}, 'descriptionModule': {'briefSummary': 'The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to three US sites will be used in this study for enrollment. Participants will be recruited from the following clinics: nursing home, memory clinic, primary and/or specialty care in order to recruit subjects with a range of hearing functions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English.\n\nExclusion Criteria:\n\n* Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.'}, 'identificationModule': {'nctId': 'NCT05848804', 'briefTitle': 'Hearing Screener Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Linus Health, Inc.'}, 'officialTitle': 'Linus Health Hearing Screening Clinical Study', 'orgStudyIdInfo': {'id': 'HSCS-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '27587', 'city': 'Wake Forest', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Woolever', 'role': 'CONTACT', 'email': 'davidjwoolever@gmail.com'}, {'name': 'David Woolever', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Crossover Mangement', 'geoPoint': {'lat': 35.97987, 'lon': -78.50972}}], 'centralContacts': [{'name': 'William I Morrow', 'role': 'CONTACT', 'email': 'imorrow@linus.health', 'phone': '9196141515'}, {'name': 'Russell Banks, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Joyce Gomes-Osman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linus Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linus Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}