Clinical trial NCT04749524: Otoacoustic Emission Suppression Study
Official title: Otoacoustic Emission Suppression in Clinical Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Hearing Loss
Lead sponsor: Intelligent Hearing Systems
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Vanderbilt University
First posted: 2021-02-11
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia

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.

Detailed description: The objective of this study is to develop an optimized hearing testing method using otoacoustic emissions, that can be used to efficiently assess peripheral neural function (including retrocochlear disorders) using the medial olivocochlear reflex (MOCR). Measuring neural function via the MOCR. This reflex has been shown to be abnormal in patients with neural disorders. The focus of this project will be the development of a screening method that incorporates OAE screening and measurement of the MOCR in the same test procedure. The target population in the proposed research is infants, particularly those in environments where auditory brainstem response (ABR) screening is not performed routinely. Addition of the MOCR to screening where ABR is not performed will address the shortcoming of OAE screening which misses neural forms of hearing loss.

Eligibility criteria: Inclusion Criteria:

* Normal middle-ear function
* Present TEOAEs.

Exclusion Criteria:

* Atresia or other external ear abnormalities not allowing recording of OAEs

Primary outcomes:
measure: Otoacoustic Suppression Measure
timeFrame: Within 48 hours of measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical School
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical School
name: Linda J Hood, PHD
role: STUDY_DIRECTOR
affiliation: Intelligent Hearing Systems Corp
name: Rafael E Delgado, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hood 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.
citation: Abdala 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.