Hearing Loss, SensorineuralNCT01022710
Early Detection of Noise-Induced Hearing Loss
An observational study of Hearing Loss, Sensorineural, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans reporting to the VA Loma Linda Healthcare System identified with sensorineural hearing loss
Who may be able to join
- Veterans 18-65 years old
Who cannot join
- Individuals with no measurable distortion-product otoacoustic emissions (DPOAEs) since the goal of the study is to relate DPOAEs to hearing function
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357
About this study
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.
Read the detailed description
The overall goal of the proposed research is to identify features of distortion product otoacoustic emissions (DPOAEs) that will eventually improve clinical methods for the early detection of noise-induced hearing loss (NIHL), which is a major sensory disability suffered by military Veterans, in particular. Toward this end, a special-purpose DPOAE measure the investigators call an augmented will be obtained. These DP-grams will test the notion that subtle post-noise changes in the DPOAE response space can be more sensitively identified when the f2 and basal source DPOAEs are isolated by the use of an interference tone (IT) and vector subtraction methods than by the commonly employed standard DP-gram procedures. The term 'augmented' maps or DP-grams was coined to describe these frequency functions when obtained with the IT present in that, under this condition, the basal source that 'fills in' or 'masks' the damage pattern is removed. The discovery of the contaminating basal source promises to modify the hearing field's current knowledge concerning the fundamental processes underlying DPOAE generation, and may also lead to the development of DPOAE tests that more sensitively identify the earliest stages of NIHL. Such tests may also be useful in Veterans, who are clinic patients and often have significant preexisting hearing losses in that higher-level primary tones can be used to increase the signal-to-noise ratio (SNR) while maintaining their sensitivity and frequency specificity. The investigators will test the ability of augmented DP-grams elicited by higher-level primary tones to uncover damaged regions in Veterans with NIHL. The notion examined here is that high-level primary tones will be more useful under conditions of preexisting hearing loss than conventional low-level primaries using the optimized augmented DP-gram by removing basal sources that come into play to obscure damaged cochlear regions as primary-tone levels are increased. Together, the combined experiments will provide a more complete understanding of the generation of DPOAEs, which will permit the creation of a useful clinical test for diagnosing and monitoring the development of NIHL.
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- hearing loss, otoacoustic emissions
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Veterans with sensorineural hearing loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
DP-gram with interference tone 1/3 octave above f2
Measured: At the end of the testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2015
- Study completionDec 2015 (estimated)
Why it stopped: We did not enroll any subjects because we realized we needed to establish the technique more definitively before proceeding to human testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Glen K Martin, PhD, Principal investigator, VA Loma Linda Healthcare System, Loma Linda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022710
- Sponsor's protocol ID
- C7107-R
- Other IDs
- 00860
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2009
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19275280Martin 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.
PubMed 21117746Martin 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.
PubMed 21568412Martin 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.
PubMed 23862812
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Noise-Induced Hearing Loss
- ClinicalTrials.gov ID
- NCT01022710
- Acronym / sponsor ID
- C7107-R
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- hearing loss, otoacoustic emissions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We did not enroll any subjects because we realized we needed to establish the technique more definitively before proceeding to human testing.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of the proposed research is to identify features of distortion product otoacoustic emissions (DPOAEs) that will eventually improve clinical methods for the early detection of noise-induced hearing loss (NIHL), which is a major sensory disability suffered by military Veterans, in particular. Toward this end, a special-purpose DPOAE measure the investigators call an augmented will be obtained. These DP-grams will test the notion that subtle post-noise changes in the DPOAE response space can be more sensitively identified when the f2 and basal source DPOAEs are isolated by the use of an interference tone (IT) and vector subtraction methods than by the commonly employed standard DP-gram procedures. The term 'augmented' maps or DP-grams was coined to describe these frequency functions when obtained with the IT present in that, under this condition, the basal source that 'fills in' or 'masks' the damage pattern is removed. The discovery of the contaminating basal source promises to modify the hearing field's current knowledge concerning the fundamental processes underlying DPOAE generation, and may also lead to the development of DPOAE tests that more sensitively identify the earliest stages of NIHL. Such tests may also be useful in Veterans, who are clinic patients and often have significant preexisting hearing losses in that higher-level primary tones can be used to increase the signal-to-noise ratio (SNR) while maintaining their sensitivity and frequency specificity. The investigators will test the ability of augmented DP-grams elicited by higher-level primary tones to uncover damaged regions in Veterans with NIHL. The notion examined here is that high-level primary tones will be more useful under conditions of preexisting hearing loss than conventional low-level primaries using the optimized augmented DP-gram by removing basal sources that come into play to obscure damaged cochlear regions as primary-tone levels are increased. Together, the combined experiments will provide a more complete understanding of the generation of DPOAEs, which will permit the creation of a useful clinical test for diagnosing and monitoring the development of NIHL.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Veterans with sensorineural hearing loss |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans reporting to the VA Loma Linda Healthcare System identified with sensorineural hearing loss
Key inclusion criteria (1 listed)
- Veterans 18-65 years old
Key exclusion criteria (1 listed)
- Individuals with no measurable distortion-product otoacoustic emissions (DPOAEs) since the goal of the study is to relate DPOAEs to hearing function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DP-gram with interference tone 1/3 octave above f2
Time frame: At the end of the testing session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Results publication: PubMed 19275280Martin 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.
- Results publication: PubMed 21117746Martin 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.
- Results publication: PubMed 21568412Martin 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.
- Results publication: PubMed 23862812Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen K Martin, PhD principal investigator
VA Loma Linda Healthcare System, Loma Linda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DP-gram with interference tone 1/3 octave above f2 (time frame: At the end of the testing session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022710, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.