Otoacoustic Emission Suppression Study
1 other identifier
observational
236
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
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
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2023
CompletedResults Posted
Study results publicly available
August 16, 2024
CompletedAugust 16, 2024
August 1, 2024
3.2 years
February 4, 2021
July 11, 2024
August 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Otoacoustic Suppression Measure
The decibel (dB) Sound Pressure Level (SPL) of the otoacoustic emission (OAE) response will be measured when recorded with and without an elicitor. The dB difference between the two measures, the OAE suppression, is used to calculate the Medial-Olivocochlear Reflex (MOCR) Strength. The elicitor is presented using a temporally separated and spectrally separated method, resulting in the two MOCR Strength measurements reported.
Within 48 hours of measurement
Study Arms (4)
Newborns
Newborns from NICU or well-baby nursery.
Newborn Hearing Screening Results
Newborns identified as having difficulty passing newborn hearing screening.
Adults with Normal Hearing
Adults with normal hearing thresholds.
Participants with Neural Hearing Loss
Participants, children and adults, with neural hearing loss.
Interventions
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Eligibility Criteria
Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia
You may qualify if:
- Normal middle-ear function
- Present TEOAEs.
You may not qualify if:
- Atresia or other external ear abnormalities not allowing recording of OAEs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical School
Nashville, Tennessee, 37232, United States
Related Publications (3)
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.
PMID: 14552424BACKGROUNDHood 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.
PMID: 8951438BACKGROUNDAbdala 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.
PMID: 23363111BACKGROUND
Limitations and Caveats
The measurement of the medial-olivocochlear reflex (MOCR) using otoacoustic emissions (OAEs) as the assay requires that participants have present OAEs. Thus, participants who do not have OAEs, which can be due to middle-ear problems or sensorineural hearing loss affecting cochlear active processes, would not be candidates for this type of measure. OAEs are low amplitude signals that are generated from the inner ear. Therefore, a quiet participant and quiet test environment are required.
Results Point of Contact
- Title
- Dr. Rafael E. Delgado
- Organization
- Intelligent Hearing Systems Corp
Study Officials
- STUDY DIRECTOR
Linda J Hood, PHD
Vanderbilt University Medical School
- PRINCIPAL INVESTIGATOR
Rafael E Delgado, PHD
Intelligent Hearing Systems Corp
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 11, 2021
Study Start
April 1, 2020
Primary Completion
June 23, 2023
Study Completion
July 12, 2023
Last Updated
August 16, 2024
Results First Posted
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals. In addition, a de-identified database containing subject gender, age at recording, raw MOCR recordings, recording parameters and spectral analysis parameters will be maintained. The data will be shared with other centers conducting similar research under appropriate IRB approval.