ClinicalTrials.gg
RecruitingNCT05670496Updated Oct 29, 2026

Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.

An observational study in Hearing Loss and Deafness, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD). Recruiting at 1 site in United States. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Primary conditionDeafnessRegistry: Hearing LossReclassifiedWhy we changed it
Registry
Hearing Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Deafness
Why
  1. The study's listed conditions name Deafness, a narrower term within Hearing Loss.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD) · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
2 Years to 99 Years
Sex
All
01

Study summary

Background:

People with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research.

Objective:

This natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies.

Eligibility:

People aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible.

Design:

Participants will be screened. Their medical records will be reviewed.

Participants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits.

All tests done will be the normal care for each participant s condition. No tests will be done solely for research.

Some of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans.

All tests will be explained. Participants may ask questions at any time.

Participants may remain in this study for up to 2 years. If they need further care, they may sign a new consent.

...

Read the detailed description

Study Description:

It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance, taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with hearing, balance and communication disorders by the NIDCD CRP, Clinical Center, and consult services as well as to provide a repository of information on enrolled subjects to allow for hypothesis generation in future research. No investigational therapies will be administered in this study. As part of hypothesisgenerating research related to taste and oral sensation, participants may undergo brief sensory testing using food-grade tannic acid solutions. This testing is designed to characterize taste, mouthfeel, and chemesthetic responses and does not involve administration of investigational agents or swallowing of test solutions.

Objectives:

  • To provide a repository of data and samples collected from clinical data or specimens generated in the diagnosis and treatment of hearing, balance, taste, smell, voice, speech, language, and other ENT disorders to allow for hypothesis generation in future research.
  • To evaluate patients to determine candidacy for intramural clinical studies
02

Conditions studied

  • Hearing Loss
  • Deafness

Browse trials for

Keywords

  • Deafness
  • Hearing
  • Speech
  • Vestibular
  • Audiology
  • Natural History
03

In context

Deafness Reclassified

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 600 is above the median of 101 across 47 observational studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD) is the lead sponsor of 37 studies on the registry; 7 are open to participants now.

Compared within Deafness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
2 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance and communication disorders referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

  • Patients must be age 2 years or older if procedures or treatment are required.
  • Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance, taste, smell, voice, speech, language, and other ENT disorder.
  • An NIDCD clinical investigator and PI determines it is in the interest of the patient/individual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD/NIH
  • Patient or their Legally Authorized Representative is able to provide . The consent form will be signed by parents or guardians of patients under the age of 18.
  • A subset of enrolled participants with known or suspected PIEZO2-related sensory dysfunction may be asked to participate in the remote taste and oral somatosensory testing procedures. Participation in this component is optional and not required for enrollment or continued participation in the parent protocol.

Exclusion criteria

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Candidates who do not meet the inclusion criteria.
  • Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care

Participants without known or suspected PIEZO2-related sensory dysfunction will not be asked to complete the sensory testing component. Additional exclusion criteria for taste testing only procedures include:

  • Active oral sores, open cuts, or significant oral pain
  • Recent oral surgery or dental procedures within the past 7 days
  • Known allergy or to tannins or polyphenols
  • Acute upper respiratory infection or conditions that may interfere with taste perception
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)

Groups and cohorts

  • Patients

    Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance or communication disorder.

06

What researchers measure

Primary outcomes

  1. Clinical data collection

    To collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance and communication disorders

    Time frame: Ongoing

  2. Evaluation for clinical studies

    To evaluate patients to determine candidacy for intramural clinical studies

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05670496
Responsible party
Sponsor
First posted
Jan 4, 2023
Start date
Mar 8, 2023
Primary completion
Aug 1, 2027 (estimated)
Completion
Dec 1, 2032 (estimated)
Last update
Oct 29, 2026

Study contacts

Marcia L Mulquin, R.N.
Contact
mmulquin@mail.nih.gov
(227) 215-4574
Joshua M Levy, M.D.
Contact
joshua.levy@nih.gov
(240) 935-8305
Joshua M Levy, M.D.
principal investigator · National Institute on Deafness and Other Communication Disorders (NIDCD)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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