Hearing LossNCT05670496
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
An observational study of Hearing Loss and Deafness, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Hearing Loss, Deafness
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 1 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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
- Conditions
- Hearing Loss, Deafness
- Keywords
- Deafness, Hearing, Speech, Vestibular, Audiology, Natural History
- Medical subject headings
- Hearing Loss, Deafness, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance or communication disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical data collection
To collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance and communication disorders
Measured: Ongoing
Evaluation for clinical studies
To evaluate patients to determine candidacy for intramural clinical studies
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start8 Mar 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joshua M Levy, M.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670496
- Sponsor's protocol ID
- 10001126
- Other IDs
- 001126-DC
- Status last verified
- 22 Oct 2026
- First submitted
- 31 Dec 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
- ClinicalTrials.gov ID
- NCT05670496
- Acronym / sponsor ID
- 10001126
- Conditions
- Hearing Loss, Deafness
- Keywords
- Deafness, Hearing, Speech, Vestibular, Audiology, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance or communication disorder. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical data collection
Time frame: Ongoing
To collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance and communication disorders
Evaluation for clinical studies
Time frame: Ongoing
To evaluate patients to determine candidacy for intramural clinical studies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua M Levy, M.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Deafness, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcia L Mulquin, R.N. ((227) 215-4574, mmulquin@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical data collection (time frame: Ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.