Otoacoustic Emission Suppression Study

NCT ID: NCT04749524

Last Updated: 2024-08-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-07-12

Brief Summary

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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

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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.

Conditions

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Neonatal Hearing Loss

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Newborn Hearing Screening Results

Newborns identified as having difficulty passing newborn hearing screening.

Medial-Olivocochlear Reflex (MOCR) Strength Measurement

Intervention Type DIAGNOSTIC_TEST

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.

Medial-Olivocochlear Reflex (MOCR) Strength Measurement

Intervention Type DIAGNOSTIC_TEST

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.

Medial-Olivocochlear Reflex (MOCR) Strength Measurement

Intervention Type DIAGNOSTIC_TEST

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

Newborns

Newborns from NICU or well-baby nursery.

Medial-Olivocochlear Reflex (MOCR) Strength Measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Normal middle-ear function
* Present TEOAEs.

Exclusion Criteria

* Atresia or other external ear abnormalities not allowing recording of OAEs
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Intelligent Hearing Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda J Hood, PHD

Role: STUDY_DIRECTOR

Vanderbilt University Medical School

Rafael E Delgado, PHD

Role: PRINCIPAL_INVESTIGATOR

Intelligent Hearing Systems Corp

Locations

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Vanderbilt University Medical School

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Hood LJ, Berlin CI, Bordelon J, Rose K. Patients with auditory neuropathy/dys-synchrony lack efferent suppression of transient evoked otoacoustic emissions. J Am Acad Audiol. 2003 Aug;14(6):302-13.

Reference Type BACKGROUND
PMID: 14552424 (View on PubMed)

Hood LJ, Berlin CI, Hurley A, Cecola RP, Bell B. Contralateral suppression of transient-evoked otoacoustic emissions in humans: intensity effects. Hear Res. 1996 Nov 1;101(1-2):113-8. doi: 10.1016/s0378-5955(96)00138-4.

Reference Type BACKGROUND
PMID: 8951438 (View on PubMed)

Abdala C, Mishra S, Garinis A. Maturation of the human medial efferent reflex revisited. J Acoust Soc Am. 2013 Feb;133(2):938-50. doi: 10.1121/1.4773265.

Reference Type BACKGROUND
PMID: 23363111 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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MOCR

Identifier Type: -

Identifier Source: org_study_id

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