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Protocol Details

Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000141-DC

Sponsoring Institute

National Institute on Deafness and Other Communication Disorders (NIDCD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Biomarkers;
immunoprofiling;
Auditory

Recruitment Keyword(s)

None

Condition(s)

Meniere's disease;
Enlarged Vestibular Aqueduct Syndrome;
autoimmune inner ear disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Deafness and Other Communication Disorders

Background:

Disorders of hearing instability (HI) are poorly characterized and ineffectively treated. HI can cause fluctuations in hearing thresholds and speech understanding. Researchers want to use a specialized form of magnetic resonance imaging (MRI) and blood tests to learn more about HI.

Objective:

To characterize a cohort of people with HI and to correlate HI with other data, including hearing evaluations, as well as radiologic and immunologic biomarkers of inflammation over time.

Eligibility:

Adults ages 18-65 who have symptoms consistent with possible HI.

Design:

Participants will be screened with a medical and hearing history and medical record review.

Participants will have physical exams. Their head and neck will be examined. They will have blood drawn.

Participants will have hearing tests. They will wear headphones or foam earplugs. They will listen to different tones. They may describe what they hear.

Participants will have balance tests. They will wear goggles as they watch moving lights or while cold or warm air is blown into their ears. They will sit in a spinning chair in a quiet, dark booth. From a reclining position, they will raise their head while clicking sounds are played into their ears.

Participants will have MRIs of the inner ear and brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head. They will get a contrast agent through an intravenous catheter.

Participation will last up to 15 months.

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Eligibility

NCLUSION CRITERIA:

Affected Adults

In order to be eligible to participate in this study as a subject with HI, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent.

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. All genders, aged 18-65 years

Diagnosed with hearing instability, defined as documented hearing instability on serial audiometry with sensorineural hearing loss (SNHL) greater than 30 dB HL at one or more frequencies (Jose A. Lopez-Escamez et al., 2015) on at least one hearing test. Inclusion will require documentation of clinically significant change in hearing (either worsening or improvement) between at least 2 hearing tests or documentation of a sudden change in hearing. Clinically significant change in hearing will be defined by a change of10 dB at any three frequencies, 15 dB at any two frequencies, or at least 20 dB at one frequency. A sudden change in hearing will be defined as at least a 30 dB difference at 3 consecutive frequencies in the affected ear as compared to the contralateral ear (Chandrasekhar et al., 2019).

4. No air-bone gaps in excess of 10 dB for 500-4000 Hz indicative of conductive HL.

5. Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally, defined as middle ear pressure between plus minus 100 deca Pascals, and peak compensated static compliance between 0.3-1.5 milliliters (Margolis & Heller, 1987)

6. For females of reproductive potential: Negative pregnancy test at start of study

Unaffected Adults

In order to be eligible to participate in this study as a healthy volunteer, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent.

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. All genders, aged 18-65 years

4. No air-bone gaps in excess of 10 dB for 500-4000Hz indicative of conductive HL.

5. Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally, defined as middle ear pressure between plus minus 100 deca Pascals, and peak compensated static compliance between 0.3-1.5 milliliters (Margolis & Heller, 1987)

6. For females of reproductive potential: Negative pregnancy test at start of study

EXCLUSION CRITERIA:

Affected and unaffected individuals who meet any of the following criteria will be excluded from participation in this study:

1. Presence of non-MRI compatible devices (cardiac pacemaker, meta<specific devices (e.g., cardiac pacemaker)

2. Pregnancy or lactation

3. Known allergic reactions to gadolinium

4. Febrile illness within 2 weeks that could affect immune profiling*

5. Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic ear canal, otorrhea)

6. History of chronic, as defined by fluid in the middle ear for more than 4 months, or recurrent otitis media, as defined by more than 4 episodes of acute otitis media in one year.

7. Current PE tubes

8. Bilateral profound (Pure tone average (PTA) > 90 dB HL) sensorineural hearing loss

9. History or diagnosis of a central nervous system disorder, including but not limited to:

a. Intracranial tumors

b. Cerebrovascular disease

c. Degenerative CNS disorder

d. CNS trauma

e. Encephalitis

f. Meningitis

10. Unable to discontinue medications that can interfere with vestibular test results for the 48 hours immediately preceding a vestibular study session. These include any and all anti-dizziness medications (such as Antivert), alcohol, caffeine, prescription pain medications (such as Percocet), prescription headache medications (such as Imitrex), sleeping pills (such as Ambien), anti-seizure medications (such as Topamax), and/or antihistamines (such as Benadryl).

11. Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) of schizophrenia, bipolar disorder, or psychosis.

12. Unstable intercurrent illness that in the judgment of the PI could prevent or confound collection of data.

Prospective study subjects who are cognitively impaired and lack consent capacity, will not be enrolled.

*Participants suspected of having COVID-19 will be moved to the designated COVID-19 unit and tested for SARS CoV-2 and Respiratory Pathogen Panel per guidance from NIH CC Clinical Practice Safety Guidelines. Possible COVID-19 infections identified by phone screen will not be eligible for study protocol until infection resolved.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Michael Hoa, M.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIHBC 35A - PNRC II BG RM 1F-226
35A CONVENT DR
BETHESDA MD 20892
(301) 435-3455
michael.hoa@nih.gov

Anna E. Clements Centeno
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health
Building 10
Room 4-2750
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1215
anna.clements@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04806282

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