Recruiting

Observational Study

Sponsor:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Code:

NCT05670496

Conditions

Hearing Loss

Deafness

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

...

Conditions

Hearing Loss

Deafness

Study ID

NCT05670496

Start date

Mar 8, 2023

Status verified date

Apr 24, 2026

Completion date

Dec 1, 2032

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

  • 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 informed consent. 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:

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 hypersensitivity to tannins or polyphenols
  • Acute upper respiratory infection or conditions that may interfere with taste perception

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

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

Primary outcome measure

  • Clinical data collection [ Time Frame: Ongoing ]
  • Evaluation for clinical studies [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Marcia L Mulquin, R.N.

(227) 215-4574mmulquin@mail.nih.gov

Joshua M Levy, M.D.

(240) 935-8305joshua.levy@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Last update posted

Aug 18, 2026

Last verified

Apr 24, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Deafness and Other Communication Disorders (NIDCD) on 2026-08-18.