Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| Vanderbilt University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newborns | Newborns from NICU or well-baby nursery. |
| |
| Newborn Hearing Screening Results | Newborns identified as having difficulty passing newborn hearing screening. |
| |
| Adults with Normal Hearing | Adults with normal hearing thresholds. |
| |
| Participants with Neural Hearing Loss | Participants, children and adults, with neural hearing loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial-Olivocochlear Reflex (MOCR) Strength Measurement | Diagnostic Test | Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 hours of measurement |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Linda J Hood, PHD | Vanderbilt University Medical School | Study Director |
| Rafael E Delgado, PHD | Intelligent Hearing Systems Corp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical School | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14552424 | Background | 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. | |
| 8951438 | Background | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Newborns | Newborns |
| FG001 | Newborn Hearing Screening | Newborns identified as having difficulty passing newborn hearing screening. |
| FG002 | Adults With Normal Hearing | Adults with normal hearing thresholds |
| FG003 | Participants With Neural Hearing Loss | Participants having a neural hearing loss. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Newborns | Newborns from NICU or well-baby nursery. |
| BG001 | Newborn Hearing Screening Results | Newborns identified as having difficulty passing newborn hearing screening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | dB - Unitless Difference in dB SPL | Within 48 hours of measurement |
|
48 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Newborns | Newborns from NICU or well-baby nursery | 0 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rafael E. Delgado | Intelligent Hearing Systems Corp | 305-668-6102 | redelgado@ihsys.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 15, 2024 | Aug 15, 2024 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
| 23363111 | Background | 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. |
| BG002 | Adults With Normal Hearing | Adults with normal hearing thresholds. |
| BG003 | Participants With Neural Hearing Loss | Participants with neural hearing loss. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Newborn Hearing Screening Results | Newborns identified as having difficulty passing newborn hearing screening. |
| OG002 | Adults With Normal Hearing | Adults with normal hearing thresholds. |
| OG003 | Participants With Neural Hearing Loss | Participants with neural hearing loss. |
|
|
| 166 |
| 0 |
| 166 |
| 0 |
| 166 |
| EG001 | Newborn Hearing Screening Results | Newborns identified as having difficulty passing newborn hearing screening. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Adults With Normal Hearing | Adults with normal hearing thresholds. | 0 | 45 | 0 | 45 | 0 | 45 |
| EG003 | Participants With Neural Hearing Loss | Participants with neural hearing loss. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
|