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
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.
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.
Adults ages 18-65 who have symptoms consistent with possible HI.
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
Documented hearing instability
- Phenomic features [ Time Frame: Day 90, 180, 270, 360, and 450, respectively +/- 14 days ]To identify phenotype features associated with hearing fluctuation
- 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.
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
|Contact: Anna E Clements||(301) email@example.com|
|Contact: Michael Hoa, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Michael Hoa, M.D.||National Institute on Deafness and Other Communication Disorders (NIDCD)|