- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04749524
Otoacoustic Emission Suppression Study
December 13, 2023 updated by: Intelligent Hearing Systems
Otoacoustic Emission Suppression in Clinical Populations
The focus of this project is on a physiologic auditory response called the Medial Olivocochlear Reflex (MOCR) that assesses peripheral neural function.
While neural hearing loss is a significant auditory disorder in patients of all ages, more than 50% of newborn infants are screened with a technology that is not sensitive to abnormalities in neural function.
The development of a time-efficient and sensitive test system to assess the MOCR will provide significant benefit to infants and patients of all ages with neural deficits who would otherwise go undetected.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to develop an optimized hearing testing method using otoacoustic emissions, that can be used to efficiently assess peripheral neural function (including retrocochlear disorders) using the medial olivocochlear reflex (MOCR).
Measuring neural function via the MOCR.
This reflex has been shown to be abnormal in patients with neural disorders.
The focus of this project will be the development of a screening method that incorporates OAE screening and measurement of the MOCR in the same test procedure.
The target population in the proposed research is infants, particularly those in environments where auditory brainstem response (ABR) screening is not performed routinely.
Addition of the MOCR to screening where ABR is not performed will address the shortcoming of OAE screening which misses neural forms of hearing loss.
Study Type
Observational
Enrollment (Actual)
243
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia
Description
Inclusion Criteria:
- Normal middle-ear function
- Present TEOAEs.
Exclusion Criteria:
- Atresia or other external ear abnormalities not allowing recording of OAEs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Newborns
Otoacoustic Emissions to be measured with and without suppression noise
|
Otoacoustic emissions will be recorded using an ear probe with and without a suppression noise.
|
Newborns failing initial hearing screening test
Otoacoustic Emissions to be measured with and without suppression noise
|
Otoacoustic emissions will be recorded using an ear probe with and without a suppression noise.
|
Adults with normal hearing
Otoacoustic Emissions to be measured with and without suppression noise
|
Otoacoustic emissions will be recorded using an ear probe with and without a suppression noise.
|
Adults with hearing loss
Otoacoustic Emissions to be measured with and without suppression noise
|
Otoacoustic emissions will be recorded using an ear probe with and without a suppression noise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Otoacoustic Suppression Measure
Time Frame: Immediately after the intervention
|
The amplitude of the otoacoustic emission response will be measured when recorded with and without a suppression noise.
|
Immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Linda J Hood, PHD, Vanderbilt University Medical School
- Principal Investigator: Rafael E Delgado, PHD, Intelligent Hearing Systems Corp
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hood LJ, Berlin CI, Bordelon J, Rose K. Patients with auditory neuropathy/dys-synchrony lack efferent suppression of transient evoked otoacoustic emissions. J Am Acad Audiol. 2003 Aug;14(6):302-13.
- Hood LJ, Berlin CI, Hurley A, Cecola RP, Bell B. Contralateral suppression of transient-evoked otoacoustic emissions in humans: intensity effects. Hear Res. 1996 Nov 1;101(1-2):113-8. doi: 10.1016/s0378-5955(96)00138-4.
- James AL. The assessment of olivocochlear function in neonates with real-time distortion product otoacoustic emissions. Laryngoscope. 2011 Jan;121(1):202-13. doi: 10.1002/lary.21078.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
June 23, 2023
Study Completion (Actual)
July 12, 2023
Study Registration Dates
First Submitted
February 4, 2021
First Submitted That Met QC Criteria
February 8, 2021
First Posted (Actual)
February 11, 2021
Study Record Updates
Last Update Posted (Actual)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOCR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals.
In addition, a de-identified database containing subject gender, age at recording, raw MOCR recordings, recording parameters and spectral analysis parameters will be maintained.
The data will be shared with other centers conducting similar research under appropriate IRB approval.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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