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

April 3, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

The Generation and Chronicity of Tinnitus in Patients With Sudden Sensorineural Hearing Loss: Insights From fMRI and Serum Metabolomics Analysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The incidence rate of tinnitus is very high globally and shows an increasing trend year by year. Sudden sensorineural hearing loss (SSNHL) , a prevalent otolaryngological emergency, often coincides with tinnitus among its patient population. This condition can significantly impact individuals' interpersonal relationships, work performance, and daily functioning, ultimately leading to a diminished quality of life and even psychological disturbances, such as anxiety and depression. Consequently, it is imperative to expore the mechanisms underlying the emergence and chronicity of tinnitus following SSNHL, and to devise targeted intervention strategies aimed at preventing the chronicity of tinnitus.

This study aims to enroll 30 patients with SSNHL accompanied by tinnitus, 30 patients with SSNHL without tinnitus, and 30 healthy subjects. Investigators will record general demographic information, tinnitus symptom characteristics, audiological examinations, vestibular function tests, and other information for each group during the acute phase of SSNHL onset. Using functional magnetic resonance imaging (fMRI), investigators will compare the brain functional states of patients with SSNHL accompanied by tinnitus and those without tinnitus during the acute phase to investigate the peripheral influencing factors and central mechanisms of tinnitus production. Additionally, investigators will conduct metabolomics analysis to compare the serum metabolite profiles of these two patient groups to identify serum metabolic biomarkers and prognostic biomarkers for tinnitus in patients with SSNHL accompanied by tinnitus. Furthermore, this study will conduct follow-up assessments on the subjects at 1 month, 3 months, and 6 months after the onset of SSNHL, reviewing changes in their symptom characteristics, audiological examinations, and fMRI. At 6 months after the onset, patients will be divided into a tinnitus recovery group and a tinnitus non-recovery group based on their tinnitus recovery status. Investigators will compare the general demographic characteristics, audiological examinations, and brain functional MRI findings between the two groups to explore the role and mechanisms of brain plasticity changes in the recovery or chronicity of tinnitus in patients with SSNHL.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with SSNHL and individuals undergoing physical examination at the Department of Otolaryngology, the First Affiliated Hospital of Nanjing Medical University

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SSNHL with Tinnitus
Patients diagnosed with sudden sensorineural hearing loss accompanied with acute occuring tinnitus symptoms
SSNHL without Tinnitus
Patients diagnosed with sudden sensorineural hearing loss without acute occuring tinnitus symptoms
Health Control
Healthy subjects with normal hearing and no tinnitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain function states
Time Frame: Acute phase (within 5 days after onset), 1 month, 3 months, and 6 months after onset
Fractional amplitude of low-frequency fluctuation, regional homogeneity, and functional connection will be compared among different groups using fMRI. Morever, the connections between the default mode network (DMN), central executive network (CEN), and salience network (SN) will be assessed through fMRI.
Acute phase (within 5 days after onset), 1 month, 3 months, and 6 months after onset
Serum metabolomics
Time Frame: Acute phase (within 5 days after onset)
Serum metabolic profiles and characteristics will be gained and compared in patients SSNHL with or with tinnitus, using LC-MS metabolomics technology.
Acute phase (within 5 days after onset)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Liyuan Zhang, M.D., Department of Otolaryngology, the First Affiliated Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-SR-116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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