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Withdrawn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
About this trial
This is an interventional diagnostic trial for Hearing Loss focused on measuring Hum Test, Weber test, audiogram
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
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
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Withdrawn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
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Validating the Hum Test
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