NCT05670496 Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
| NCT ID | NCT05670496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Condition | Hearing Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-03-08 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-03-08 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. ...
Eligibility Criteria
* 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
Contact & Investigator
Joshua M Levy, M.D.
PRINCIPAL INVESTIGATOR
National Institute on Deafness and Other Communication Disorders (NIDCD)
Frequently Asked Questions
Who can join the NCT05670496 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 99 Years, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05670496 currently recruiting?
Yes, NCT05670496 is actively recruiting participants. Contact the research team at mmulquin@mail.nih.gov for enrollment information.
Where is the NCT05670496 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05670496 clinical trial?
NCT05670496 is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD). The principal investigator is Joshua M Levy, M.D. at National Institute on Deafness and Other Communication Disorders (NIDCD). The trial plans to enroll 600 participants.