Hearing DisordersWAI-MEMRNCT04875637
Middle-ear Reflex Testing Using Wideband Acoustic Immittance
A study testing WAI-MEMR in people with Hearing Disorders, run by Mimosa Acoustics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hearing Disorders
- What is being tested?
- WAI-MEMR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal hearing or hearing loss
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Linda J Hood, Ph.D., 615-936-6920, Linda.j.hood@vanderbilt.edu
Research Audiologist, 615-936-6920
About this study
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.
Read the 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.
- Conditions
- Hearing Disorders
- Being tested
- WAI-MEMR
- Keywords
- middle ear muscle reflex, wideband acoustic immittance
- Medical subject headings
- Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAI-MEMRDiagnostic test
Using wideband acoustic reflectance for middle-ear muscle reflex.
| Study group | Role | What they receive |
|---|---|---|
| MEMR Diagnostic Evaluation | Other | Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status. Receives: Diagnostic Test: WAI-MEMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
WAI-MEMR
MEMR threshold
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start21 Jan 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mimosa Acoustics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875637
- Sponsor's protocol ID
- WAI-MEMR-MA-16780-02
- Acronym
- WAI-MEMR
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle-ear Reflex Testing Using Wideband Acoustic Immittance
- ClinicalTrials.gov ID
- NCT04875637
- Acronym / sponsor ID
- WAI-MEMR / WAI-MEMR-MA-16780-02
- Conditions
- Hearing Disorders
- Keywords
- middle ear muscle reflex, wideband acoustic immittance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Mimosa AcousticsIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEMR Diagnostic Evaluation | Other | Diagnostic Test: WAI-MEMRMiddle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Normal hearing or hearing loss
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAI-MEMRUsing wideband acoustic reflectance for middle-ear muscle reflex. | Diagnostic test | MEMR Diagnostic Evaluation |
Primary outcome
WAI-MEMR
Time frame: Through study completion, an average of 2 years
MEMR threshold
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAI-MEMR in people with Hearing Disorders, run by Mimosa Acoustics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Jeng, Ph.D. (217 359 9740, psj@mimosaacoustics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WAI-MEMR (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.