Study Stopped
We did not enroll any subjects because we realized we needed to establish the technique more definitively before proceeding to human testing.
Early Detection of Noise-Induced Hearing Loss
2 other identifiers
observational
N/A
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2010
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 24, 2015
December 1, 2015
5.4 years
November 25, 2009
December 22, 2015
Conditions
Keywords
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
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
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.
PMID: 19275280RESULTMartin 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.
PMID: 21117746RESULTMartin 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.
PMID: 21568412RESULTMartin 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.
PMID: 23862812RESULT
Biospecimen
No biospecimens will be collected for this study
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glen K Martin, PhD
VA Loma Linda Healthcare System, Loma Linda, CA
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