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OpenTrials
Completed

NCT Number: NCT04749524

Otoacoustic Emission Suppression Study

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.

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Key information

Conditions

Neonatal Hearing Loss

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical School

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal middle-ear function
  • Present TEOAEs.

Exclusion criteria

  • Atresia or other external ear abnormalities not allowing recording of OAEs

Treatment and study plan

Medial-Olivocochlear Reflex (MOCR) Strength Measurement

Diagnostic Test

Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Intelligent Hearing Systems

Industry

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Vanderbilt University

Registry information

Official study title

Otoacoustic Emission Suppression in Clinical Populations

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2021
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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