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Search / Trial NCT06355102

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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Apr 3, 2024

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

Sudden Sensorineural Hearing Loss Tinnitus Chronicity Functional Magnetic Resonance Imaging Metabolomics

ClinConnect Summary

This study is watching how tinnitus (ringing in the ears) starts and sticks around in people who have sudden sensorineural hearing loss (SSNHL). Researchers in Nanjing, China will compare three groups: people with SSNHL who have tinnitus, people with SSNHL who do not have tinnitus, and healthy people with normal hearing. They want to learn what brain activity and blood-blood chemical patterns are linked to tinnitus, in hopes of someday predicting who will develop it and how it might change over time.

About 90 adults aged 18–65 are planned to take part: 30 with SSNHL and tinnitus, 30 with SSNHL but no tinnitus, and 30 healthy controls. Participants will undergo hearing and balance tests, brain MRI scans, and a blood test during the first days after onset, with follow-ups at 1, 3, and 6 months. This is an observational study, not testing a treatment, and it aims to identify brain network changes and serum biomarkers that relate to tinnitus development and recovery. Eligible people should be adults within the age range, diagnosed with SSNHL within 5 days, and able to complete the tests, while those with other ear or brain diseases or MRI safety issues would be excluded. The study is currently enrolling by invitation and is expected to wrap up around March 2026.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Group of SSNHL with Tinnitus:
  • 1. Age between 18 and 65 years old;
  • 2. Meets the diagnostic criteria for SSNHL; untreated within 5 days after onset;
  • 3. Presence of tinnitus;
  • 4. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
  • 2. Group of SSNHL without Tinnitus:
  • 1. Age between 18 and 65 years old;
  • 2. Meets the diagnostic criteria for SSNHL; untreated within 5 days after onset;
  • 3. Absence of tinnitus;
  • 4. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
  • 3. Healthy Control:
  • 1. Age between 18 and 65 years old;
  • 2. Normal hearing screening results;
  • 3. Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
  • Exclusion Criteria:
  • 1. 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;
  • 2. Presence of brain organic diseases such as cerebral infarction, brain tumor, or contraindications for functional magnetic resonance imaging (fMRI) during nuclear magnetic resonance (NMR) examination;
  • 3. History of mental illness, including anxiety, depression, insomnia, etc.;
  • 4. Individuals unable to cooperate due to severe mental factors.

About The First Affiliated Hospital With Nanjing Medical University

The First Affiliated Hospital of Nanjing Medical University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to implementing rigorous scientific methodologies to evaluate new therapies and treatment approaches. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital fosters a collaborative environment aimed at enhancing patient outcomes and contributing to the global medical community. Its strategic focus on translational medicine ensures that groundbreaking discoveries are efficiently translated into practical applications for patient care.

Locations

Nanjing, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Liyuan Zhang, M.D.

Principal Investigator

Department of Otolaryngology, the First Affiliated Hospital, Nanjing Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported