Trial Outcomes & Findings for Otoacoustic Emission Suppression Study (NCT NCT04749524)
NCT ID: NCT04749524
Last Updated: 2024-08-16
Results Overview
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.
COMPLETED
236 participants
Within 48 hours of measurement
2024-08-16
Participant Flow
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).
Participant milestones
| Measure |
Newborns
Newborns
|
Newborn Hearing Screening
Newborns identified as having difficulty passing newborn hearing screening.
|
Adults With Normal Hearing
Adults with normal hearing thresholds
|
Participants With Neural Hearing Loss
Participants having a neural hearing loss.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
166
|
22
|
45
|
3
|
|
Overall Study
COMPLETED
|
166
|
22
|
45
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Otoacoustic Emission Suppression Study
Baseline characteristics by cohort
| Measure |
Newborns
n=166 Participants
Newborns from NICU or well-baby nursery.
|
Newborn Hearing Screening Results
n=22 Participants
Newborns identified as having difficulty passing newborn hearing screening.
|
Adults With Normal Hearing
n=45 Participants
Adults with normal hearing thresholds.
|
Participants With Neural Hearing Loss
n=3 Participants
Participants with neural hearing loss.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
0.014 years
STANDARD_DEVIATION 0.049 • n=39 Participants
|
0.072 years
STANDARD_DEVIATION 0.047 • n=41 Participants
|
29.23 years
STANDARD_DEVIATION 6.34 • n=35 Participants
|
15.67 years
STANDARD_DEVIATION 6.43 • n=31 Participants
|
4.77 years
STANDARD_DEVIATION 10.97 • n=146 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
128 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
108 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
29 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
175 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
166 participants
n=39 Participants
|
22 participants
n=41 Participants
|
45 participants
n=35 Participants
|
3 participants
n=31 Participants
|
236 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Within 48 hours of measurementPopulation: 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.
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.
Outcome measures
| Measure |
Newborns
n=45 Participants
Newborns from NICU or well-baby nursery.
|
Newborn Hearing Screening Results
n=22 Participants
Newborns identified as having difficulty passing newborn hearing screening.
|
Adults With Normal Hearing
n=23 Participants
Adults with normal hearing thresholds.
|
Participants With Neural Hearing Loss
n=3 Participants
Participants with neural hearing loss.
|
|---|---|---|---|---|
|
Otoacoustic Suppression Measure
MOCR Strength (Spectrally Separated Method)
|
1.95 dB - Unitless Difference in dB SPL
Standard Deviation 1.41
|
1.33 dB - Unitless Difference in dB SPL
Standard Deviation 1.22
|
2.48 dB - Unitless Difference in dB SPL
Standard Deviation 1.74
|
0.36 dB - Unitless Difference in dB SPL
Standard Deviation 0.32
|
|
Otoacoustic Suppression Measure
MOCR Strength (Temporally Separated Method)
|
1.57 dB - Unitless Difference in dB SPL
Standard Deviation 2.22
|
—
|
1.79 dB - Unitless Difference in dB SPL
Standard Deviation 1.10
|
0.35 dB - Unitless Difference in dB SPL
Standard Deviation 0.18
|
Adverse Events
Newborns
Newborn Hearing Screening Results
Adults With Normal Hearing
Participants With Neural Hearing Loss
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place