- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02740322
Validating the Hum Test
Validation of the Hum Test, a Simple and Reliable Alternative to the Weber Test
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Erich Voigt, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-00102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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