NCT04875637

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 5, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

April 28, 2021

Last Update Submit

July 30, 2021

Conditions

Hearing Disorders

Keywords

middle ear muscle reflexwideband acoustic immittance

Outcome Measures

Primary Outcomes (1)

  • WAI-MEMR

    MEMR threshold

    Through study completion, an average of 2 years

Study Arms (1)

MEMR Diagnostic Evaluation

OTHER

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

Diagnostic Test: WAI-MEMR

Interventions

WAI-MEMRDIAGNOSTIC_TEST

Using wideband acoustic reflectance for middle-ear muscle reflex.

MEMR Diagnostic Evaluation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Normal hearing or hearing loss

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Hearing Disorders

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Jeng, Ph.D.

CONTACT

217 359 9740psj@mimosaacoustics.com

Christopher Manrique, AA

CONTACT

217 359 9740crmanrique@mimosaacoustics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 6, 2021

Study Start

January 21, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 5, 2021

Record last verified: 2021-07

Locations

US(1)