Trial Outcomes & Findings for Otoacoustic Emission Suppression Study (NCT 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.

Recruitment status

COMPLETED

Target enrollment

236 participants

Primary outcome timeframe

Within 48 hours of measurement

Results posted on

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

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

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=5 Participants	0.072 years STANDARD_DEVIATION 0.047 • n=7 Participants	29.23 years STANDARD_DEVIATION 6.34 • n=5 Participants	15.67 years STANDARD_DEVIATION 6.43 • n=4 Participants	4.77 years STANDARD_DEVIATION 10.97 • n=21 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	6 Participants n=7 Participants	42 Participants n=5 Participants	1 Participants n=4 Participants	128 Participants n=21 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	16 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	108 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants	3 Participants n=4 Participants	175 Participants n=21 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	17 Participants n=21 Participants
Region of Enrollment United States	166 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants	3 participants n=4 Participants	236 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Newborn Hearing Screening Results

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adults With Normal Hearing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With Neural Hearing Loss

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rafael E. Delgado

Intelligent Hearing Systems Corp

Phone: 305-668-6102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place