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

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ClinicalTrials.gov Identifier: NCT04806282
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )

Brief Summary:

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.

...


Condition or disease
Meniere's Disease Enlarged Vestibular Aqueduct Syndrome Autoimmune Inner Ear Disease

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030


Group/Cohort
1/All Patients
Documented hearing instability



Primary Outcome Measures :
  1. Phenomic features [ Time Frame: Day 90, 180, 270, 360, and 450, respectively +/- 14 days ]
    To identify phenotype features associated with hearing fluctuation


Secondary Outcome Measures :
  1. Subdivisions of phenomic features [ Time Frame: Day 90, 180, 270, 360, and 450, respectively +/- 14 days ]
    To Identify a variety of phenomic features of patients with HI that allow assignment to clinical subdivisions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will enroll up to a total of 150 patients with HI. The enrollment target is between 10-30 patients per clinical subtype for at least 2 clinical subtypes of HI (i.e., without or with EH, without or with significant immune cell, cytokine or FLAIR positivity). 20 cytokines/chemokines in patients with Meniere s disease that revealed statistically higher levels of IL-1Beta compared to healthy controls (Flook et al., 2019), a sample size of 40-50 patients would be required for 80% power to detect an immune subtype associated with IL-1Beta.
Criteria
  • INCLUSION CRITERIA:

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
  4. 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 of 10 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).
  5. No air-bone gaps in excess of 10 dB for 500-4000 Hz indicative of conductive HL.
  6. Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally, defined as middle ear pressure between plus minus 100 decaPascals, and peak compensated static compliance between 0.3-1.5 milliliters (Margolis & Heller, 1987)
  7. For females of reproductive potential: Negative pregnancy test at start of study

EXCLUSION CRITERIA:

An individual who meets 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:

    1. Intracranial tumors
    2. Cerebrovascular disease
    3. Degenerative CNS disorder
    4. CNS trauma
    5. Encephalitis
    6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806282


Contacts
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Contact: Anna E Clements (301) 451-1215 anna.clements@nih.gov
Contact: Michael Hoa, M.D. (301) 435-3455 michael.hoa@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Michael Hoa, M.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
Additional Information:
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Responsible Party: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT04806282    
Other Study ID Numbers: 10000141
000141-DC
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: February 10, 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) ):
Auditory
immunoprofiling
Biomarkers
Natural History
Additional relevant MeSH terms:
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Meniere Disease
Ear Diseases
Labyrinth Diseases
Labyrinthitis
Endolymphatic Hydrops
Otorhinolaryngologic Diseases
Otitis