Neonatal Hearing Loss
Conditions
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.
Interventions
DIAGNOSTIC_TESTMedial-Olivocochlear Reflex (MOCR) Strength Measurement
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Vanderbilt University
Intelligent Hearing Systems
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Normal middle-ear function * Present TEOAEs.
Exclusion criteria
* Atresia or other external ear abnormalities not allowing recording of OAEs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Otoacoustic Suppression Measure | Within 48 hours of measurement | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the general Vanderbilt University community and surrounding area population (children 6 years and older and adults with normal hearing), audiology clinics (infant, children 6 years and older, and adults with hearing loss), and infants at the Newborn (Well-Baby) Nursery and the Neonatal Intensive Care Unit (NICU) at the Vanderbilt Monroe Carell Jr. Children's Hospital (VCH).
Participants by arm
| Arm | Count |
|---|---|
| Newborns Newborns from NICU or well-baby nursery. | 166 |
| Newborn Hearing Screening Results Newborns identified as having difficulty passing newborn hearing screening. | 22 |
| Adults With Normal Hearing Adults with normal hearing thresholds. | 45 |
| Participants With Neural Hearing Loss Participants with neural hearing loss. | 3 |
| Total | 236 |
Baseline characteristics
| Characteristic | Newborns | Total | Participants With Neural Hearing Loss | Adults With Normal Hearing | Newborn Hearing Screening Results |
|---|---|---|---|---|---|
| Age, Continuous | 0.014 years STANDARD_DEVIATION 0.049 | 4.77 years STANDARD_DEVIATION 10.97 | 15.67 years STANDARD_DEVIATION 6.43 | 29.23 years STANDARD_DEVIATION 6.34 | 0.072 years STANDARD_DEVIATION 0.047 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 29 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 8 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 17 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 115 Participants | 175 Participants | 3 Participants | 39 Participants | 18 Participants |
| Region of Enrollment United States | 166 participants | 236 participants | 3 participants | 45 participants | 22 participants |
| Sex: Female, Male Female | 79 Participants | 128 Participants | 1 Participants | 42 Participants | 6 Participants |
| Sex: Female, Male Male | 87 Participants | 108 Participants | 2 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 22 | 0 / 45 | 0 / 3 |
| other Total, other adverse events | 0 / 166 | 0 / 22 | 0 / 45 | 0 / 3 |
| serious Total, serious adverse events | 0 / 166 | 0 / 22 | 0 / 45 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Within 48 hours of measurement
Population: Results from subjects with high ambient or physiological acoustic noise were excluded. For the Newborn Hearing Screening group, only the spectrally separated MOCR Strength method was used due to time limitations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newborns | Otoacoustic Suppression Measure | MOCR Strength (Spectrally Separated Method) | 1.95 dB - Unitless Difference in dB SPL | Standard Deviation 1.41 |
| Newborns | Otoacoustic Suppression Measure | MOCR Strength (Temporally Separated Method) | 1.57 dB - Unitless Difference in dB SPL | Standard Deviation 2.22 |
| Newborn Hearing Screening Results | Otoacoustic Suppression Measure | MOCR Strength (Spectrally Separated Method) | 1.33 dB - Unitless Difference in dB SPL | Standard Deviation 1.22 |
| Adults With Normal Hearing | Otoacoustic Suppression Measure | MOCR Strength (Temporally Separated Method) | 1.79 dB - Unitless Difference in dB SPL | Standard Deviation 1.1 |
| Adults With Normal Hearing | Otoacoustic Suppression Measure | MOCR Strength (Spectrally Separated Method) | 2.48 dB - Unitless Difference in dB SPL | Standard Deviation 1.74 |
| Participants With Neural Hearing Loss | Otoacoustic Suppression Measure | MOCR Strength (Spectrally Separated Method) | 0.36 dB - Unitless Difference in dB SPL | Standard Deviation 0.32 |
| Participants With Neural Hearing Loss | Otoacoustic Suppression Measure | MOCR Strength (Temporally Separated Method) | 0.35 dB - Unitless Difference in dB SPL | Standard Deviation 0.18 |