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Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe) (HearMe)

Primary Purpose

Hearing Loss, Hearing Disorders, Hearing Abnormality

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HearMe Smartphone Application
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hearing Loss focused on measuring Smartphone, Medical application, Hearing-in-noise test, Digits-in-noise test, Speech reception threshold, Hearing Loss, Hearing Disorders, Hearing Abnormalities, Tinnitus, Hearing aids, Cochlear implants

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hearing Loss Group

    Control Group

    Arm Description

    The investigators will characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the HearMe app in patients with hearing loss.

    The investigators will characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the HearMe app in control subjects without any prior or current hearing loss.

    Outcomes

    Primary Outcome Measures

    Standardized Hearing Tests (change in hearing)
    Pure-tone audiometry threshold (threshold of hearing relative to frequency)

    Secondary Outcome Measures

    Quick Hearing Check Questionnaire (change in hearing)
    Better Hearing Institute Quick Hearing Check (15 items; score 1-60, higher = better hearing, lower = worse hearing)
    Standardized Hearing Loss Questionnaire (change in hearing)
    2009 Spatial Hearing Questionnaire (24 items, scored 1-100; higher = better hearing, lower = worse hearing)
    Tinnitus Questionnaires (change in hearing)
    Tinnitus Activities Questionnaire; Tinnitus Handicap Questionnaire (27 items, scored 1-100%; lower = less effects of tinnitus)

    Full Information

    First Posted
    January 19, 2018
    Last Updated
    July 20, 2021
    Sponsor
    University of Iowa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03429777
    Brief Title
    Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe)
    Acronym
    HearMe
    Official Title
    Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of novelty of study
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    May 1, 2023 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Iowa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Age-related hearing loss, or presbycusis, is highly prevalent among the elderly. It can have a major impact on the quality of life due to progressive communication difficulties that may lead to psychosocial dysfunction and in extreme cases to social isolation and depression. Hearing aids and cochlear implants have evolved rapidly over the past decades and may strongly improve quality of life in elderly with hearing loss. Nevertheless, it is estimated that in the US and Europe only one out of five to six people with substantial hearing loss is actually using hearing aids. In fact, nearly 50% of people with hearing loss never underwent a hearing test at all. This may be due to denial of illness associated with aging or to disbelieve in bene t from hearing aids or cochlear implants. Hearing screening could increase awareness of hearing loss among elderly and identify those who might bene t from amplification. However, classical audiometry (i.e. pure- tone thresholds and speech-recognition in quiet) is not ideal for screening purposes as it is time consuming and it requires expensive equipment including a soundproof booth and a calibrated audiometer. Over the past decades, several Speech-In-Noise tests were developed to get a better assessment of a person's hearing ability in real-life situations. These tests generally measure the speech reception threshold (SRT) in dB signal to noise ratio (SNR). SRT is determined as the difference between the level of presented speech and background noise at which the tested per- son can correctly reproduce 50% of words or sentences. It is now generally recognized that the SRT is more representative of a patient's hearing ability in real-life situations than pure- tone audiometry or speech recognition in quiet. The Speech- In-Noise test, based on spoken sentences, is still being used in clinical practice. However, its general use for a broad clinical population has been disputed because not every person is able to understand and repeat complete sentences in noise, regardless of his hearing loss. This test is there- fore considered as an assessment of the entire auditory system, including memory and certain linguistic aspects, rather than of hearing loss alone. In 2013, the Digits-In-Noise (DIN) test was developed, overcoming several shortcomings of the previous telephone test. It uses, for example, wideband signals instead of the limited telephone bandwidth and concatenating digits, spoken by a male voice. The DIN test requires listeners to repeat three spoken numbers (a so-called digit triplet) presented through a headphone, while a continuous noise is presented synchronously to the same ear. The response is then scored correct or incorrect automatically by the computer. Depending on the test setting, the response can either be imputed by the listener him- self or by an administrator. By using simple digits in a closed set paradigm, the contribution of top-down processing and thus the influence of cognitive status is thought to be minimized. For this test, no learning effect was detected, low measurement errors were reported (0.7 dB SNR for normal-hearing listeners) and high validity was claimed by comparing measured digit- triplet SRTs and sentence SRTs. Although SRT-in-noise reflects different aspects of hearing acuity than pure-tone thresholds, both measures are also highly correlated. Previously reported correlation coefficients vary from 0.77 to 0.86. These studies included populations with a wide range of hearing losses, varying from severe to no hearing loss at all. Based on this relationship, the DIN test could potentially be used as a screening instrument for hearing loss. However, these two studies did not report specifically on a population of elderly subjects, and this is one of the main target groups for hearing screening. It is important to validate the assumed relationship between SRT-in-noise and hearing loss for this particular population with a smartphone, as it may be influenced by general aging, for example, a decline in cognitive skills. The purpose of this project is to validate a quick, easy-to-use and administer smartphone hearing-in-noise test. 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 we will test at least 50 participants with hearing loss and 50 control subjects between the ages of 18-80. The participants 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 participant 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). With this study, the investigators aim to evaluate the developed smartphone HINT/DIN test for its ability to screen the elderly for hearing loss. The investigators hope to examine the relationship between pure-tone thresholds and SRT-in-noise as measured by the HearMe smartphone application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Hearing Disorders, Hearing Abnormality, Hearing Disability, Tinnitus
    Keywords
    Smartphone, Medical application, Hearing-in-noise test, Digits-in-noise test, Speech reception threshold, Hearing Loss, Hearing Disorders, Hearing Abnormalities, Tinnitus, Hearing aids, Cochlear implants

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    For this study the investigators will test at least 50 subjects with some form or 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 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.
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hearing Loss Group
    Arm Type
    Experimental
    Arm Description
    The investigators will characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the HearMe app in patients with hearing loss.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    The investigators will characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the HearMe app in control subjects without any prior or current hearing loss.
    Intervention Type
    Device
    Intervention Name(s)
    HearMe Smartphone Application
    Other Intervention Name(s)
    HearMe, HearMe IA
    Intervention Description
    The HearMe smartphone application is a digits-in-noise test that can be used to digitally quantify speech reception thresholds.
    Primary Outcome Measure Information:
    Title
    Standardized Hearing Tests (change in hearing)
    Description
    Pure-tone audiometry threshold (threshold of hearing relative to frequency)
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Quick Hearing Check Questionnaire (change in hearing)
    Description
    Better Hearing Institute Quick Hearing Check (15 items; score 1-60, higher = better hearing, lower = worse hearing)
    Time Frame
    Through study completion, an average of 1 year
    Title
    Standardized Hearing Loss Questionnaire (change in hearing)
    Description
    2009 Spatial Hearing Questionnaire (24 items, scored 1-100; higher = better hearing, lower = worse hearing)
    Time Frame
    Through study completion, an average of 1 year
    Title
    Tinnitus Questionnaires (change in hearing)
    Description
    Tinnitus Activities Questionnaire; Tinnitus Handicap Questionnaire (27 items, scored 1-100%; lower = less effects of tinnitus)
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zarei
    Organizational Affiliation
    University of Iowa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no intent to make IPD available to other researchers, besides the results published in a peer-reviewed journal publication.
    Citations:
    PubMed Identifier
    22791988
    Citation
    Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15.
    Results Reference
    background
    PubMed Identifier
    16450920
    Citation
    Culling JF, Zhao F, Stephens D. The viability of speech-in-noise audiometric screening using domestic audio equipment. Int J Audiol. 2005 Dec;44(12):691-700. doi: 10.1080/14992020500267017.
    Results Reference
    background
    PubMed Identifier
    14570962
    Citation
    Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.
    Results Reference
    background
    PubMed Identifier
    17927921
    Citation
    Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420.
    Results Reference
    background
    PubMed Identifier
    8844552
    Citation
    DePaolis RA, Janota CP, Frank T. Frequency importance functions for words, sentences, and continuous discourse. J Speech Hear Res. 1996 Aug;39(4):714-23. doi: 10.1044/jshr.3904.714.
    Results Reference
    background
    PubMed Identifier
    23636208
    Citation
    Grant KW, Walden TC. Understanding excessive SNR loss in hearing-impaired listeners. J Am Acad Audiol. 2013 Apr;24(4):258-73; quiz 337-8. doi: 10.3766/jaaa.24.4.3.
    Results Reference
    background
    PubMed Identifier
    18569101
    Citation
    Houtgast T, Festen JM. On the auditory and cognitive functions that may explain an individual's elevation of the speech reception threshold in noise. Int J Audiol. 2008 Jun;47(6):287-95. doi: 10.1080/14992020802127109.
    Results Reference
    background
    PubMed Identifier
    24237040
    Citation
    Jansen S, Luts H, Dejonckere P, van Wieringen A, Wouters J. Exploring the sensitivity of speech-in-noise tests for noise-induced hearing loss. Int J Audiol. 2014 Mar;53(3):199-205. doi: 10.3109/14992027.2013.849361. Epub 2013 Nov 18.
    Results Reference
    background
    PubMed Identifier
    15532670
    Citation
    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. doi: 10.1121/1.1784440. Erratum In: J Acoust Soc Am. 2006 Mar;119(3):1888.
    Results Reference
    background
    PubMed Identifier
    27121117
    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.
    Results Reference
    background
    Links:
    URL
    http://acousticalsociety.org
    Description
    American National Standard, Methods for Calculation of the Speech Intelligibility Index.

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