Otoacoustic Emission Suppression Study

Sponsor
Intelligent Hearing Systems (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04749524
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), Vanderbilt University (Other)
310
1
38.9
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measurement of Otoacoustic Emissions with and without suppression noise

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 Design

Study Type:
Observational
Anticipated Enrollment :
310 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Otoacoustic Emission Suppression in Clinical Populations
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Newborns

Otoacoustic Emissions to be measured with and without suppression noise

Diagnostic Test: Measurement of Otoacoustic Emissions 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

Diagnostic Test: Measurement of Otoacoustic Emissions 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

Diagnostic Test: Measurement of Otoacoustic Emissions 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

Diagnostic Test: Measurement of Otoacoustic Emissions with and without suppression noise
Otoacoustic emissions will be recorded using an ear probe with and without a suppression noise.

Outcome Measures

Primary Outcome Measures

  1. Otoacoustic Suppression Measure [Immediately after the intervention]

    The amplitude of the otoacoustic emission response will be measured when recorded with and without a suppression noise.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Normal middle-ear function

  • Present TEOAEs.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical School Nashville Tennessee United States 37232

Sponsors and Collaborators

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

Investigators

  • Study Director: Linda J Hood, PHD, Vanderbilt University Medical School
  • Principal Investigator: Rafael E Delgado, PHD, Intelligent Hearing Systems Corp

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Intelligent Hearing Systems
ClinicalTrials.gov Identifier:
NCT04749524
Other Study ID Numbers:
  • MOCR
First Posted:
Feb 11, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022