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

NCT06355102 | Enrolling By Invitation DMC

• 1 other identifier: 2024-SR-116
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sudden Sensorineural Hearing Loss; Tinnitus

Keywords

Sudden sensorineural hearing loss; Tinnitus chronicity; Functional magnetic resonance imaging; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Brain function states

  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

  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)

Study Arms (3)

SSNHL with Tinnitus

Patients diagnosed with sudden sensorineural hearing loss accompanied with acute occuring tinnitus symptoms.

Other: Conventional treatment and care

SSNHL without Tinnitus

Patients diagnosed with sudden sensorineural hearing loss without acute occuring tinnitus symptoms.

Other: Conventional treatment and care

Health Control

Healthy subjects with normal hearing and no tinnitus.

Other: Conventional treatment and care

Interventions

Conventional treatment and care OTHER

Conventional treatment and care

Health Control; SSNHL with Tinnitus; SSNHL without Tinnitus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;
• Absence of tinnitus;
• Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.
• Healthy Control:
• Age between 18 and 65 years old;
• Normal hearing screening results;
• Able to complete questionnaires independently and cooperate with fMRI and follow-up assessments.

You may not qualify if:

• 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;
• 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;
• History of mental illness, including anxiety, depression, insomnia, etc.;
• Individuals unable to cooperate due to severe mental factors.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210029, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study collects serum samples from subjects for the purpose of serum metabolomics research, and relevant samples will be destroyed after the completion of the study.

MeSH Terms

Conditions

Hearing Loss, Sudden; Tinnitus

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liyuan Zhang, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 9, 2024
• Study Start: April 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CN (1)