Otoacoustic Emission Suppression Study

August 15, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

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

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical School

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Newborns
Newborns from NICU or well-baby nursery.
Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Newborn Hearing Screening Results
Newborns identified as having difficulty passing newborn hearing screening.
Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Adults with Normal Hearing
Adults with normal hearing thresholds.
Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Participants with Neural Hearing Loss
Participants, children and adults, with neural hearing loss.
Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Otoacoustic Suppression Measure
Time Frame: Within 48 hours of measurement
The decibel (dB) Sound Pressure Level (SPL) of the otoacoustic emission (OAE) response will be measured when recorded with and without an elicitor. The dB difference between the two measures, the OAE suppression, is used to calculate the Medial-Olivocochlear Reflex (MOCR) Strength. The elicitor is presented using a temporally separated and spectrally separated method, resulting in the two MOCR Strength measurements reported.
Within 48 hours of measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intelligent Hearing Systems

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vanderbilt University
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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