The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics : The Generation and Chronicity of Tinnitus in Patients With Sudden Sensorineural Hearing Loss: Insights From fMRI and Serum Metabolomics Analysis
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..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 09. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: April 9, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 |
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| Study ID: |
NCT06355102 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG009669310 |
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| 245 | 1 | 0 | |a The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics |b The Generation and Chronicity of Tinnitus in Patients With Sudden Sensorineural Hearing Loss: Insights From fMRI and Serum Metabolomics Analysis |
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| 520 | |a 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. | ||
| 650 | 2 | |a Hearing Loss | |
| 650 | 2 | |a Deafness | |
| 650 | 2 | |a Tinnitus | |
| 650 | 2 | |a Hearing Loss, Sensorineural | |
| 650 | 4 | |a Study Type: Observational | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
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