Neonatal Hearing LossNCT04749524

Otoacoustic Emission Suppression Study

An observational study of Neonatal Hearing Loss, run by Intelligent Hearing Systems at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Neonatal Hearing Loss
What is being tested?: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
How many people: 236 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2020to 12 Jul 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia

Who may be able to join

Normal middle-ear function
Present TEOAEs.

Who cannot join

Atresia or other external ear abnormalities not allowing recording of OAEs

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical School
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Otoacoustic Emission Suppression in Clinical Populations

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.

Read the 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.

Conditions: Neonatal Hearing Loss
Being tested: Medial-Olivocochlear Reflex (MOCR) Strength Measurement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medial-Olivocochlear Reflex (MOCR) Strength MeasurementDiagnostic test
Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.

Study groups in NCT04749524
Study group	Role	What they receive
Newborns		Newborns from NICU or well-baby nursery. Receives: Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Newborn Hearing Screening Results		Newborns identified as having difficulty passing newborn hearing screening. Receives: Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Adults with Normal Hearing		Adults with normal hearing thresholds. Receives: Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement
Participants with Neural Hearing Loss		Participants, children and adults, with neural hearing loss. Receives: Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 48 hours of measurement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202012 Jul 2023

First posted11 Feb 2021
Study start1 Apr 2020
Primary completion23 Jun 2023
Study completion12 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Neonatal Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Other
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04749524
Sponsor's protocol ID: MOCR
Status last verified: Aug 2024
First submitted: 4 Feb 2021
Last updated: 16 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 14552424
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.
PubMed 8951438
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.
PubMed 23363111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
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RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)

All Neonatal Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Otoacoustic Emission Suppression in Clinical Populations
ClinicalTrials.gov ID: NCT04749524
Acronym / sponsor ID: MOCR
Conditions: Neonatal Hearing Loss
Study type: Observational
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: Intelligent Hearing SystemsIndustry (pharma, biotech, devices)
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University
Study start: 1 Apr 2020 (actual)
Primary completion: 23 Jun 2023 (actual)
Study completion: 12 Jul 2023 (actual)
First posted: 11 Feb 2021 (actual)
Results: Posted 16 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Other
Number of arms: 4

Arm	Type	Receives
Newborns	–	Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength MeasurementNewborns from NICU or well-baby nursery.
Newborn Hearing Screening Results	–	Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength MeasurementNewborns identified as having difficulty passing newborn hearing screening.
Adults with Normal Hearing	–	Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength MeasurementAdults with normal hearing thresholds.
Participants with Neural Hearing Loss	–	Diagnostic Test: Medial-Olivocochlear Reflex (MOCR) Strength MeasurementParticipants, children and adults, with neural hearing loss.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia

Key inclusion criteria (2 listed)

Normal middle-ear function
Present TEOAEs.

Key exclusion criteria (1 listed)

Atresia or other external ear abnormalities not allowing recording of OAEs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medial-Olivocochlear Reflex (MOCR) Strength MeasurementOtoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.	Diagnostic test	Adults with Normal Hearing, Newborn Hearing Screening Results, Newborns, Participants with Neural Hearing Loss

Primary outcome

Otoacoustic Suppression Measure
Time frame: 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.

Results and safety

Results posted to the registry on 16 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Newborns	166	166
Newborn Hearing Screening	22	22
Adults With Normal Hearing	45	45
Participants With Neural Hearing Loss	3	3

Primary outcome: Otoacoustic Suppression Measure

Time frame: Within 48 hours of measurement. Mean (Standard Deviation). Unit: dB - Unitless Difference in dB SPL

Measure	Newborns n = 45	Newborn Hearing Screening Results n = 22	Adults With Normal Hearing n = 23	Participants With Neural Hearing Loss n = 3
MOCR Strength (Spectrally Separated Method)	1.95 (1.41)	1.33 (1.22)	2.48 (1.74)	0.36 (0.32)
MOCR Strength (Temporally Separated Method)	1.57 (2.22)	–	1.79 (1.10)	0.35 (0.18)

Population analysed: 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.

Adverse events

Time frame: 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Newborns	0 of 166 (0%)	0 of 166 (0%)	0 of 166
Newborn Hearing Screening Results	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Adults With Normal Hearing	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Participants With Neural Hearing Loss	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14552424Hood 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.
Background: PubMed 8951438Hood 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.
Background: PubMed 23363111Abdala 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.
Individual participant dataSharing planned: No. 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.

Related trials for Neonatal Hearing Loss

Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linda J Hood, PHD study director

Vanderbilt University Medical School

Rafael E Delgado, PHD principal investigator

Intelligent Hearing Systems Corp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Hearing Loss, run by Intelligent Hearing Systems at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Otoacoustic Suppression Measure (time frame: Within 48 hours of measurement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04749524, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.