Middle-ear Reflex Testing Using Wideband Acoustic Immittance

NCT ID: NCT04875637

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2022-08-31

Brief Summary

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This project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults. The developments will facilitate clinical applications that include hearing screening and diagnostic evaluation of persons of all ages with normal hearing and with hearing loss.

Detailed Description

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Measurement of middle-ear muscle reflexes (MEMR) constitutes an important component of the standard of care in auditory function assessment and diagnostic audiology. An important component of the middle-ear test battery involves characterizing neural function through the eighth nerve-brainstem pathway which is accomplished through measurement of the MEMR. The evaluation component of this project will involve testing of human subjects using wideband acoustic immittance in the evaluation of middle-ear muscle reflexes. Subjects in this project will be infants, children and adults with normal hearing as well as with conductive, sensory, and neural hearing loss. All subjects will receive wideband acoustic immittance (WAI) and middle-ear muscle reflex (MEMR) testing. Baseline testing includes pure tone audiometry and otoacoustic emissions.

Conditions

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Hearing Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MEMR Diagnostic Evaluation

Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status.

Group Type OTHER

WAI-MEMR

Intervention Type DIAGNOSTIC_TEST

Using wideband acoustic reflectance for middle-ear muscle reflex.

Interventions

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WAI-MEMR

Using wideband acoustic reflectance for middle-ear muscle reflex.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Normal hearing or hearing loss

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Mimosa Acoustics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Jeng, Ph.D.

Role: CONTACT

217 359 9740

Christopher Manrique, AA

Role: CONTACT

217 359 9740

Facility Contacts

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Linda J Hood, Ph.D.

Role: primary

615-936-6920

Research Audiologist

Role: backup

615-936-6920

Other Identifiers

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WAI-MEMR-MA-16780-02

Identifier Type: -

Identifier Source: org_study_id

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