Hearing Loss Clinical Trial
— HearMeOfficial title:
Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe)
NCT number | NCT03429777 |
Other study ID # | 201712793 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | May 1, 2024 |
Verified date | July 2021 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this project is to validate a quick, easy-to-use and administer smartphone hearing-in-noise test. The Hearing-in-Noise Test (HINT) measures an individual's ability to hear speech in quiet and in noise. HINTs are traditionally done testing both ears together as binaural hearing ability is key in noisy settings and everyday, functional hearing. The app (called HearMe) can potentially be used to easily and quickly collect hearing-in-noise and speech-in-noise measurements. The smartphone app developed is a hearing-in-noise test that presents the subject with a series of stimuli consisting of a spoken three-digit sequence presented at a varying hearing-to-noise ratio. For each stimulus presentation, the user tap the three-digit sequence. The duration of the app is less than 3 minutes. For this project the investigators will test at least 50 subjects with hearing loss and 50 control subjects between the ages of 18-80. The subjects will be invited to take the app. The approach for this pilot study is to characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the app in both subject groups, and relate it to the phenotype of each group as a preliminary evaluation of the app as well as a preliminary validation against their routinely collected measurements of hearing function (pure-tone audiometry thresholds). The study will assess the validity of the test construct in measuring hearing-in-noise thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies. This study seeks to validate a developed smartphone HINT on an initial cohort of patients and controls. It is anticipated that patients with hearing loss will display higher signal-to-noise ratio thresholds (as measured by the iPhone app) compared to controls.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 1, 2024 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Age-matched (18-100) - Healthy normal controls with no known hearing loss - Patients with clinically assessed hearing loss Exclusion Criteria: - Complete hearing loss/deafness - Cognitive decline or dysfunction, dementia |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Iowa |
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Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. Erratum in: J Acoust Soc Am. 2006 Mar;119(3):1888. — View Citation
Potgieter JM, Swanepoel de W, Myburgh HC, Hopper TC, Smits C. Development and validation of a smartphone-based digits-in-noise hearing test in South African English. Int J Audiol. 2015 Jul;55(7):405-11. doi: 10.3109/14992027.2016.1172269. Epub 2016 Apr 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Standardized Hearing Tests (change in hearing) | Pure-tone audiometry threshold (threshold of hearing relative to frequency) | Through study completion, an average of 1 year | |
Secondary | Quick Hearing Check Questionnaire (change in hearing) | Better Hearing Institute Quick Hearing Check (15 items; score 1-60, higher = better hearing, lower = worse hearing) | Through study completion, an average of 1 year | |
Secondary | Standardized Hearing Loss Questionnaire (change in hearing) | 2009 Spatial Hearing Questionnaire (24 items, scored 1-100; higher = better hearing, lower = worse hearing) | Through study completion, an average of 1 year | |
Secondary | Tinnitus Questionnaires (change in hearing) | Tinnitus Activities Questionnaire; Tinnitus Handicap Questionnaire (27 items, scored 1-100%; lower = less effects of tinnitus) | Through study completion, an average of 1 year |
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