Middle-ear Reflex Testing Using Wideband Acoustic Immittance | NCT04875637

Studies
Middle-ear Reflex Testing Using Wideband Acoustic Immittance

NCT04875637

Sponsor

Mimosa Acoustics

Status

Unknown status

Last Update Posted

Aug 5, 2021Actual

Enrollment

326Estimated

Phase

Not Applicable

Conditions

Hearing Disorders

Interventions

WAI-MEMR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2021Actual

Primary Completion Date

Aug 31, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Apr 28, 2021

First Submission Date that Met QC Criteria

May 3, 2021

First Posted Date

May 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2021

Last Update Posted Date

Aug 5, 2021Actual

Name	Class
Vanderbilt University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

326Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MEMR Diagnostic Evaluation	Other	Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status.	Diagnostic Test: WAI-MEMR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WAI-MEMR	Diagnostic Test	Using wideband acoustic reflectance for middle-ear muscle reflex.	MEMR Diagnostic Evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WAI-MEMR	MEMR threshold	Through study completion, an average of 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal hearing or hearing loss

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Jeng, Ph.D.	Contact	217 359 9740		psj@mimosaacoustics.com
Christopher Manrique, AA	Contact	217 359 9740		crmanrique@mimosaacoustics.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center	Recruiting	Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006311	Hearing Disorders

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided