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WithdrawnNCT03429777HearMeUpdated Jul 28, 2021

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

An interventional study of HearMe Smartphone Application in Hearing Loss, Hearing Disorders and Hearing Abnormality, sponsored by University of Iowa. Withdrawn. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by University of Iowa · Not applicable, Interventional, and Screening

Why this study was withdrawn
Lack of novelty of study
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age-matched (18-100)
  • Healthy normal controls with no known hearing loss
  • Patients with clinically assessed hearing loss

Exclusion criteria

Exclusion Criteria:

  • Complete hearing loss/deafness
  • Cognitive decline or dysfunction, dementia
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Hearing Loss Group

    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.

    Device: HearMe Smartphone Application

  • Active comparator
    Control Group

    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.

    Device: HearMe Smartphone Application

Interventions

  • DeviceHearMe Smartphone Application

    The HearMe smartphone application is a digits-in-noise test that can be used to digitally quantify speech reception thresholds.

    Also known as: HearMe, HearMe IA

05

What researchers measure

Primary outcomes

  1. Standardized Hearing Tests (change in hearing)

    Pure-tone audiometry threshold (threshold of hearing relative to frequency)

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Quick Hearing Check Questionnaire (change in hearing)

    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

  2. Standardized Hearing Loss Questionnaire (change in hearing)

    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

  3. Tinnitus Questionnaires (change in hearing)

    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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 22791988 ↗
  • 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. PubMed 16450920 ↗
  • 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. PubMed 14570962 ↗
  • 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. PubMed 17927921 ↗
  • 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. PubMed 8844552 ↗
  • 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. PubMed 23636208 ↗
  • 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. PubMed 18569101 ↗
  • 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. PubMed 24237040 ↗
  • 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. PubMed 15532670 ↗
  • 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. PubMed 27121117 ↗

Study documents

  • Study protocol · Feb 2, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no intent to make IPD available to other researchers, besides the results published in a peer-reviewed journal publication.

08

Registry details

Key details

Study ID
NCT03429777
Lead sponsor
University of Iowa
Responsible party
Kasra Zarei (Student, University of Iowa) — Principal investigator
First posted
Feb 12, 2018
Start date
Aug 1, 2021 (estimated)
Primary completion
May 1, 2023 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Jul 28, 2021

Study contacts

Zarei
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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