Validating the Hum Test

Not Applicable

Withdrawn

• Conditions: Hearing Loss
• Interventions: Procedure: Hum Test; Procedure: Weber Test; Device: Audiogram

• Registration Number: NCT02740322
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hum Test	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.
Hum Test	Audiogram	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.
Hum Test	Weber 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.

Primary Outcome Measures

Name	Time	Method
The correlation between the Hum Test and the Weber Test	30 Minutes	The Weber Test will measure a subject's ability to hear vibrations in both ears.
The correlation of the results between the Hum Test and the Audiogram	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.