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Validating the Hum Test

Primary Purpose

Hearing Loss

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hum Test
Weber Test
Audiogram
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Loss focused on measuring Hum Test, Weber test, audiogram

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-35
  • Subjective normal hearing and no previous complaints or history of hearing problems or otologic disorders
  • Subjects will be NYU medical students, NYU resident physicians, or patients from the Long Island Cochlear Implant Center

Exclusion Criteria:

  • Has not had a URI (assessed by asking patient if they have had fever, cough, sore throat, nasal congestion, or runny nose) within one month of study session

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Hum Test

    Arm Description

    To examine and compare the Hum Test, Weber Test, and audiogram in their ability to detect and identify hearing loss, hearing loss will be simulated with the use of ear plugs (mimicking conductive hearing loss). Subjects will serve as their own control as these tests will be conducted with and without ear plugs.

    Outcomes

    Primary Outcome Measures

    The correlation of the results between the Hum Test and the Audiogram
    The Hum test will measure a subject's ability to hear a high pitch and a low pitch in each ear. The Audiogram will measure a subject's hearing threshold at various frequencies.
    The correlation between the Hum Test and the Weber Test
    The Weber Test will measure a subject's ability to hear vibrations in both ears.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2016
    Last Updated
    October 12, 2017
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02740322
    Brief Title
    Validating the Hum Test
    Official Title
    Validation of the Hum Test, a Simple and Reliable Alternative to the Weber Test
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI no longer at institution and no subjects enrolled
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The sensitivity and specificity of the Hum Test is being investigated in it's ability to detect conductive hearing loss. The hum test is simply elicited by asking the subject to hum to him or herself for a few seconds at both a high and low pitch that is comfortable for the subject. The subject is then asked if the hum was heard on one side more than the other (left or right), or if the sound was equal on both sides. To simulate conductive hearing loss, ear plugs will be placed in one of the subject's ears. We will elicit the hum test as well as the standard Weber test and audiogram across two conditions, with an ear plug and without an ear plug. From this, it is hoped to assess how the Hum Test compares to the audiogram (gold standard) in detecting conductive hearing loss as well as how it compares to the standard Weber test. If the Hum Test demonstrates strong sensitivity and specificity in detecting conductive hearing loss, it could have application as being utilized as an alternative to the standard Weber test, or in a setting where a formal physical examination may not yet be possible but where the etiology of a patient's hearing change could be quickly assessed remotely and thus the urgency of intervention/ consultation could then be determined.
    Detailed Description
    It is presumed that the Hum Test works similarly to the Weber Test, where bone conduction of the skull is elicited to determine if a change in hearing is conductive or sensorineural in nature. Because the hum test is frequently employed in clinical practice yet its validation has yet to be demonstrated, investigation is warranted. To examine and compare the Hum Test, Weber Test, and audiogram in their ability to detect and identify hearing loss, hearing loss will be simulated with the use of ear plugs (mimicking conductive hearing loss). Subjects will serve as their own control as these tests will be conducted with and without ear plugs. Study data will be maintained using an online, password protected storage system. No identifiable information will be collected or stored (i.e. name, DOB, etc.). Limited demographic information will be collected for analysis purposes such as age and gender.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss
    Keywords
    Hum Test, Weber test, audiogram

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hum Test
    Arm Type
    Other
    Arm Description
    To examine and compare the Hum Test, Weber Test, and audiogram in their ability to detect and identify hearing loss, hearing loss will be simulated with the use of ear plugs (mimicking conductive hearing loss). Subjects will serve as their own control as these tests will be conducted with and without ear plugs.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hum Test
    Intervention Description
    The subject will be brought into an exam room. The subject will then be asked to hum for a few seconds in a low pitch. They will then be asked if the nose was heard more so in one ear compared to the other. The subject will then be asked to hum for a few seconds in a high pitch. They will then be asked again if the noise was heard more so in one ear compared to the other.
    Intervention Type
    Procedure
    Intervention Name(s)
    Weber Test
    Intervention Description
    Using a 512 Hz tuning fork, the tuning fork will be vibrated and placed on the subject's glabella (forehead landmark). The subject will then be asked if the vibration was heard more so in one ear compared to the other.
    Intervention Type
    Device
    Intervention Name(s)
    Audiogram
    Intervention Description
    A standard audiogram will be administered by an audiologist.
    Primary Outcome Measure Information:
    Title
    The correlation of the results between the Hum Test and the Audiogram
    Description
    The Hum test will measure a subject's ability to hear a high pitch and a low pitch in each ear. The Audiogram will measure a subject's hearing threshold at various frequencies.
    Time Frame
    30 minutes
    Title
    The correlation between the Hum Test and the Weber Test
    Description
    The Weber Test will measure a subject's ability to hear vibrations in both ears.
    Time Frame
    30 Minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18-35 Subjective normal hearing and no previous complaints or history of hearing problems or otologic disorders Subjects will be NYU medical students, NYU resident physicians, or patients from the Long Island Cochlear Implant Center Exclusion Criteria: Has not had a URI (assessed by asking patient if they have had fever, cough, sore throat, nasal congestion, or runny nose) within one month of study session
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erich Voigt, MD
    Organizational Affiliation
    NYU Langone Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Validating the Hum Test

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