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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02740322
Other study ID # 15-00102
Secondary ID
Status Withdrawn
Phase N/A
First received April 5, 2016
Last updated October 12, 2017
Start date September 2015
Est. completion date May 2016

Study information

Verified date October 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hum Test
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.
Weber Test
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.
Device:
Audiogram
A standard audiogram will be administered by an audiologist.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes
Primary 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. 30 Minutes
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