Sudden Sensorineural Hearing LossNCT06355102
The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics
An observational study of Sudden Sensorineural Hearing Loss and Tinnitus, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Sensorineural Hearing Loss, Tinnitus
- What is being tested?
- Conventional treatment and care
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with SSNHL and individuals undergoing physical examination at the Department of Otolaryngology, the First Affiliated Hospital of Nanjing Medical University
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Otolaryngology, the First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Sudden Sensorineural Hearing Loss, Tinnitus
- Being tested
- Conventional treatment and care
- Keywords
- Sudden sensorineural hearing loss, Tinnitus chronicity, Functional magnetic resonance imaging, Metabolomics
- Medical subject headings
- Hearing Loss, Sudden, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatment and careOther
Conventional treatment and care
| Study group | Role | What they receive |
|---|---|---|
| SSNHL with Tinnitus | Patients diagnosed with sudden sensorineural hearing loss accompanied with acute occuring tinnitus symptoms. Receives: Other: Conventional treatment and care | |
| SSNHL without Tinnitus | Patients diagnosed with sudden sensorineural hearing loss without acute occuring tinnitus symptoms. Receives: Other: Conventional treatment and care | |
| Health Control | Healthy subjects with normal hearing and no tinnitus. Receives: Other: Conventional treatment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Acute phase (within 5 days after onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liyuan Zhang, M.D., Principal investigator, Department of Otolaryngology, the First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355102
- Sponsor's protocol ID
- 2024-SR-116
- Status last verified
- Oct 2024
- First submitted
- 12 Mar 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Generation and Chronicity of Tinnitus in Patients With Sudden Sensorineural Hearing Loss: Insights From fMRI and Serum Metabolomics Analysis
- ClinicalTrials.gov ID
- NCT06355102
- Acronym / sponsor ID
- 2024-SR-116
- Conditions
- Sudden Sensorineural Hearing Loss, Tinnitus
- Keywords
- Sudden sensorineural hearing loss, Tinnitus chronicity, Functional magnetic resonance imaging, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSNHL with Tinnitus | – | Other: Conventional treatment and carePatients diagnosed with sudden sensorineural hearing loss accompanied with acute occuring tinnitus symptoms. |
| SSNHL without Tinnitus | – | Other: Conventional treatment and carePatients diagnosed with sudden sensorineural hearing loss without acute occuring tinnitus symptoms. |
| Health Control | – | Other: Conventional treatment and careHealthy subjects with normal hearing and no tinnitus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SSNHL and individuals undergoing physical examination at the Department of Otolaryngology, the First Affiliated Hospital of Nanjing Medical University
Key inclusion criteria (14 listed)
- Group of SSNHL with Tinnitus:
- Group of SSNHL without Tinnitus:
- Healthy Control:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatment and careConventional treatment and care | Other | Health Control, SSNHL with Tinnitus, SSNHL without Tinnitus |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liyuan Zhang, M.D. principal investigator
Department of Otolaryngology, the First Affiliated Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Sensorineural Hearing Loss and Tinnitus, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain function states (time frame: Acute phase (within 5 days after onset), 1 month, 3 months, and 6 months after onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.