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

NCT05670496 | Recruiting

• 2 other identifiers: 10001126001126-DC
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

Deafness; Hearing; Speech; Vestibular; Audiology; Natural History

Outcome Measures

Primary Outcomes (2)

• Clinical data collection

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

  Ongoing

• Evaluation for clinical studies

  To evaluate patients to determine candidacy for intramural clinical studies

  Ongoing

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hearing Loss; Deafness; Speech

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Study Officials

• Joshua M Levy, M.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia L Mulquin, R.N.

CONTACT

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

Joshua M Levy, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 4, 2023
• Study Start: March 8, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 28, 2026

Record last verified: 2026-04-24

Locations

US (1)