By InvitationNot Applicable

The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics

China90 participantsStarted 2024-04-15

Plain-language summary

The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are: * What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL? * Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients? Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis. Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Group of SSNHL with Tinnitus:
✓. Age between 18 and 65 years old;
✓. Meets the diagnostic criteria for SSNHL; untreated within 5 days after onset;
✓. Presence of tinnitus;
✓. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
✓. Group of SSNHL without Tinnitus:
✓. Age between 18 and 65 years old;
✓. Meets the diagnostic criteria for SSNHL; untreated within 5 days after onset;

Exclusion criteria

✕. Previous diagnosis of otic organic diseases such as otitis media, cholesteatoma of the middle ear, Ménière's disease, acoustic neuroma, hereditary deafness, inner ear malformations, etc.; history of ear surgery; long-term exposure to noise; use of ototoxic drugs;
✕

What they're measuring

Brain function states

Timeframe: Acute phase (within 5 days after onset), 1 month, 3 months, and 6 months after onset

Serum metabolomics

Timeframe: Acute phase (within 5 days after onset)

Trial details

NCT IDNCT06355102

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Sudden Sensorineural Hearing Loss trials