Otoacoustic Emission Suppression Study

Completed

• Conditions: Neonatal Hearing Loss
• Interventions: Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement

• Registration Number: NCT04749524
• Lead Sponsor: Intelligent Hearing Systems

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.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Primary Completion: 2023-06-23
• Study Completion: 2023-07-12
• Results First Submitted: 2024-07-11
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Results First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Normal middle-ear function
• Present TEOAEs.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborns	Medial-Olivocochlear Reflex (MOCR) Strength Measurement	Newborns from NICU or well-baby nursery.
Participants with Neural Hearing Loss	Medial-Olivocochlear Reflex (MOCR) Strength Measurement	Participants, children and adults, with neural hearing loss.
Adults with Normal Hearing	Medial-Olivocochlear Reflex (MOCR) Strength Measurement	Adults with normal hearing thresholds.
Newborn Hearing Screening Results	Medial-Olivocochlear Reflex (MOCR) Strength Measurement	Newborns identified as having difficulty passing newborn hearing screening.

Primary Outcome Measures

Name	Time	Method
Otoacoustic Suppression Measure	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.

Trial Locations

Locations (1)

Vanderbilt University Medical School; 🇺🇸 Nashville, Tennessee, United States