NCT01022710

Brief Summary

This study measures sounds produced by the sensory receptors of the inner ear called hair cells. These sounds are called otoacoustic emissions and one special case the investigators are studying are called distortion product otoacoustic emissions (DPOAEs) produced by presenting two tones to the ear. If the ear is damaged by noise exposure DPOAEs are reduced. In this study the investigators are attempting to improve the DPOAE test by adding a third tone to make the test more frequency specific. Whether the third tone helps will be determined by comparing DPOAEs collected with and without the third tone to clinical audiograms. If the addition of the third tone helps then the investigators expect DPOAEs tracked as a function of frequency (DP-grams) will more closely match the clinical audiograms.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

5.4 years

First QC Date

November 25, 2009

Last Update Submit

December 22, 2015

Conditions

Keywords

hearing lossotoacoustic emissions

Outcome Measures

Primary Outcomes (1)

  • DP-gram with interference tone 1/3 octave above f2

    At the end of the testing session

Study Arms (1)

Group 1

Veterans with sensorineural hearing loss

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans reporting to the VA Loma Linda Healthcare System identified with sensorineural hearing loss

You may qualify if:

  • Veterans 18-65 years old

You may not qualify if:

  • Individuals with no measurable distortion-product otoacoustic emissions (DPOAEs) since the goal of the study is to relate DPOAEs to hearing function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357, United States

Location

Related Publications (4)

  • Martin GK, Stagner BB, Fahey PF, Lonsbury-Martin BL. Steep and shallow phase gradient distortion product otoacoustic emissions arising basal to the primary tones. J Acoust Soc Am. 2009 Mar;125(3):EL85-92. doi: 10.1121/1.3073734.

  • Martin GK, Stagner BB, Lonsbury-Martin BL. Evidence for basal distortion-product otoacoustic emission components. J Acoust Soc Am. 2010 May;127(5):2955-72. doi: 10.1121/1.3353121.

  • Martin GK, Stagner BB, Chung YS, Lonsbury-Martin BL. Characterizing distortion-product otoacoustic emission components across four species. J Acoust Soc Am. 2011 May;129(5):3090-103. doi: 10.1121/1.3560123.

  • Martin GK, Stagner BB, Lonsbury-Martin BL. Time-domain demonstration of distributed distortion-product otoacoustic emission components. J Acoust Soc Am. 2013 Jul;134(1):342-55. doi: 10.1121/1.4809676.

Biospecimen

Retention: NONE RETAINED

No biospecimens will be collected for this study

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Glen K Martin, PhD

    VA Loma Linda Healthcare System, Loma Linda, CA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

January 1, 2010

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations