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Trial record 7 of 18 for:    Recruiting, Not yet recruiting, Available Studies | "Noise"

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

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ClinicalTrials.gov Identifier: NCT03429777
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kasra Zarei, University of Iowa

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.


Condition or disease Intervention/treatment Phase
Hearing Loss Hearing Disorders Hearing Abnormality Hearing Disability Tinnitus Device: HearMe Smartphone Application Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe)
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
The HearMe smartphone application is a digits-in-noise test that can be used to digitally quantify speech reception thresholds.
Other Names:
  • HearMe
  • HearMe IA

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




Primary Outcome Measures :
  1. Standardized Hearing Tests [ Time Frame: Through study completion, an average of 1 year ]
    Pure-tone audiometry threshold


Secondary Outcome Measures :
  1. Quick Hearing Check Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Better Hearing Institute Quick Hearing Check

  2. Standardized Hearing Loss Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    2009 Spatial Hearing Questionnaire

  3. Tinnitus Questionnaires [ Time Frame: Through study completion, an average of 1 year ]
    Tinnitus Activities Questionnaire; Tinnitus Handicap Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429777


Contacts
Contact: Kasra Zarei, MS 3194300869 kasra-zarei@uiowa.edu

Locations
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Kasra Zarei, MS    319-430-0869    kasra-zarei@uiowa.edu   
Principal Investigator: Kasra Zarei, MS         
Sponsors and Collaborators
Kasra Zarei
  Study Documents (Full-Text)

Documents provided by Kasra Zarei, University of Iowa:
Study Protocol  [PDF] February 2, 2018


Additional Information:
Publications:

Responsible Party: Kasra Zarei, Medical/Graduate Student, University of Iowa
ClinicalTrials.gov Identifier: NCT03429777     History of Changes
Other Study ID Numbers: 201712793
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no intent to make IPD available to other researchers, besides the results published in a peer-reviewed journal publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kasra Zarei, University of Iowa:
Hearing-in-noise test
Digits-in-noise test
Smartphone
Medical application
Speech reception threshold
Hearing Loss
Hearing Disorders
Hearing Abnormalities
Tinnitus
Hearing aids
Cochlear implants

Additional relevant MeSH terms:
Congenital Abnormalities
Hearing Loss
Deafness
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms