Tinnitus Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
| Recruiting |
NCT04987502 -
Virtual Reality and Subjective Tinnitus
|
N/A | |
| Recruiting |
NCT04404439 -
Treatment of Tinnitus With Migraine Medications
|
Phase 4 | |
| Recruiting |
NCT05533840 -
Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
|
||
| Completed |
NCT03552302 -
Effects of Yoga Exercise on Participates With Tinnitus
|
||
| Enrolling by invitation |
NCT02617953 -
Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
|
N/A | |
| Withdrawn |
NCT01663467 -
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy
|
N/A | |
| Completed |
NCT02269839 -
A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus
|
N/A | |
| Completed |
NCT02974543 -
Somatosensory Stimulation to Alleviate Tinnitus
|
N/A | |
| Completed |
NCT01929837 -
Tinnitus rTMS 2013
|
N/A | |
| Completed |
NCT01927991 -
Internet-based Self-help for Tinnitus: The Role of Support
|
N/A | |
| Completed |
NCT01857661 -
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
|
N/A | |
| Terminated |
NCT01412918 -
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression
|
N/A | |
| Completed |
NCT01480193 -
New Therapy for Patients With Severe Tinnitus
|
N/A | |
| Completed |
NCT00748475 -
Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus
|
N/A | |
| Completed |
NCT00371436 -
Progressive Intervention Program for Tinnitus Management
|
N/A | |
| Completed |
NCT00733044 -
Cost-effectiveness of Multidisciplinary Management of Tinnitus
|
N/A | |
| Active, not recruiting |
NCT05518682 -
Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus
|
N/A | |
| Recruiting |
NCT05212298 -
Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus
|
N/A | |
| Completed |
NCT06025097 -
Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.
|
Early Phase 1 |