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Clinical Trials/NCT04749524
NCT04749524
Completed
Not Applicable

Otoacoustic Emission Suppression in Clinical Populations

Intelligent Hearing Systems1 site in 1 country236 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Hearing Loss
Sponsor
Intelligent Hearing Systems
Enrollment
236
Locations
1
Primary Endpoint
Otoacoustic Suppression Measure
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
July 12, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Intelligent Hearing Systems
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Normal middle-ear function
  • Present TEOAEs.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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