Hearing LossNCT06303180
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
An observational study of Hearing Loss and Head and Neck Neoplasms, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial summary
Background: Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- Hearing Loss, Head and Neck Neoplasms, Hearing Disorders
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 30 Dec 2033
- 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 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1000 subjects of any age, any race, ethnicity and gender. Only viable neonates will be enrolled. We are hoping to accrue about 100 subjects a year over 10 years. NIH employees and staff participating in an approved NIH protocol. There will be no collection or recruitment of healthy volunteers.
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:
- Ability to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
- Ability of subject (or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- Have a hearing, balance, smell, taste, voice, speech or language condition for which the subject is under clinical care or research purposes under a separate Review Board (IRB) approved protocol; OR be a healthy volunteer aged at least 3 years, enrolled on an approved research protocol.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction
- Have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects' risk in participating. This will be determined at the discretion of the principal investigator.
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
Marcia Mulquin, RN, MSN, 301-496-1601, mmulquin@mail.nih.gov
NIH Clinical Center Office of Patient Recruitment (OPR), (800) 411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.
Read more
Objective:
To collect biological samples for a repository that will be used for research.
Eligibility:
People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.
Design:
Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.
Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.
Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.
Samples may be used for genetic testing.
Read the detailed description
Study Description:
National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions affecting hearing, balance, smell, taste, voice, speech and language at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.
Objectives:
Primary:
To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:
- From surgical waste materials from participants of all ages in NIH protocols who have hearing, balance, smell, taste, voice, speech and language disorders.
- Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs.
- Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection.
Secondary:
The specimens may be shared with other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.
Endpoints:
The primary endpoint of this study is the creation of a NIDCD biorepository from both surgical waste material and collected blood, saliva, oral swabs, nasal secretions, oral mucosa biopsy and skin biopsy specimens.
- Keywords
- Hearing, Balance, Speech, Taste, SMELL, Tissue Sample, Genomic DNA, Saliva
- Medical subject headings
- Hearing Loss, Head and Neck Neoplasms, Hearing Disorders, Laryngeal Diseases, 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 |
|---|---|---|
| 1 | Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create a biorepository of diseased and normal tissue specimens for research purposes.
(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.
Measured: Ongoing
Secondary outcomes (1)
To share specimens with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of
These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Mar 2024
- Primary completion30 Dec 2033 (estimated)
- Study completion30 Dec 2033 (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
- 1,000 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
- NCT06303180
- Sponsor's protocol ID
- 10001560
- Other IDs
- 001560-DC
- Status last verified
- 29 Sep 2026
- First submitted
- 8 Mar 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
- ClinicalTrials.gov ID
- NCT06303180
- Acronym / sponsor ID
- 10001560
- Keywords
- Hearing, Balance, Speech, Taste, SMELL, Tissue Sample, Genomic DNA, Saliva
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Dec 2033 (estimated)
- Study completion
- 30 Dec 2033 (estimated)
- First posted
- 12 Mar 2024 (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:
Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.
Objective:
To collect biological samples for a repository that will be used for research.
Eligibility:
People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.
Design:
Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.
Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.
Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.
Samples may be used for genetic testing.
Detailed description
Study Description:
National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions affecting hearing, balance, smell, taste, voice, speech and language at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.
Objectives:
Primary:
To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:
- From surgical waste materials from participants of all ages in NIH protocols who have hearing, balance, smell, taste, voice, speech and language disorders.
- Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs.
- Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection.
Secondary:
The specimens may be shared with other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.
Endpoints:
The primary endpoint of this study is the creation of a NIDCD biorepository from both surgical waste material and collected blood, saliva, oral swabs, nasal secretions, oral mucosa biopsy and skin biopsy specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1000 subjects of any age, any race, ethnicity and gender. Only viable neonates will be enrolled. We are hoping to accrue about 100 subjects a year over 10 years. NIH employees and staff participating in an approved NIH protocol. There will be no collection or recruitment of healthy volunteers.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
- Ability of subject (or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- Have a hearing, balance, smell, taste, voice, speech or language condition for which the subject is under clinical care or research purposes under a separate Review Board (IRB) approved protocol; OR be a healthy volunteer aged at least 3 years, enrolled on an approved research protocol.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction
- Have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects' risk in participating. This will be determined at the discretion of the principal investigator.
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
To create a biorepository of diseased and normal tissue specimens for research purposes.
Time frame: Ongoing
(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.
1 secondary outcome
To share specimens with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of
Time frame: Ongoing
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 5 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Head and Neck Neoplasms, 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 4 inclusion and 3 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 5 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 Maame S Akumatey ((227) 233-0452, maame.akumatey@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To create a biorepository of diseased and normal tissue specimens for research purposes. (time frame: Ongoing). 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 5 Oct 2026.