NCT02740322

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

April 5, 2016

Last Update Submit

October 12, 2017

Conditions

Keywords

Hum Test, Weber test, audiogram

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Hum Test

OTHER

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.

Procedure: Hum TestProcedure: Weber TestDevice: Audiogram

Interventions

Hum TestPROCEDURE

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.

Hum Test
Weber TestPROCEDURE

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.

Hum Test
AudiogramDEVICE

A standard audiogram will be administered by an audiologist.

Hum Test

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss

Interventions

Audiometry

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Erich Voigt, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 15, 2016

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 16, 2017

Record last verified: 2017-10