Validating the Hum Test

October 12, 2017 updated by: NYU Langone Health

Validation of the Hum Test, a Simple and Reliable Alternative to the Weber Test

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hum Test
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.
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.
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.
A standard audiogram will be administered by an audiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation of the results between the Hum Test and the Audiogram
Time Frame: 30 minutes
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.
30 minutes
The correlation between the Hum Test and the Weber Test
Time Frame: 30 Minutes
The Weber Test will measure a subject's ability to hear vibrations in both ears.
30 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Erich Voigt, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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