Sudden Sensorineural Hearing LossNCT06365775
Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
An observational study of Sudden Sensorineural Hearing Loss and Hearing Loss, Sensorineural, run by Dan Bing.
Trial summary
The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). Read more about this study
- Who is it for?
- Ages 4 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Sensorineural Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Sudden
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2024to 23 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with SSNHL will be selected from patients diagnosed and treated at Tongji hospital. Participants in healthy controls will be recruited in public from the residents of Wuhan city, China.
Who may be able to join
- Age ≥ 4
- Participants with SSNHL: unilateral or bilateral sensorineural hearing loss of > 30 dB HL (decibel) involving at least 3 continuous test frequencies developing within 72 hours
- Healthy controls: people with PTA thresholds of all test frequencies ≤ 20 dB HL and without otologic disease in the last 3 months
- Completed informed consent and promised to finish follow-ups
Who cannot join
- Hearing loss with explicit causes, including noise-induced, Ménière's disease, ototoxicity exposure, mumps infection or history of syphilis infection and so on.
- A history of head trauma or otologic surgery.
- Malformation of temporal bone discovered by computed tomography (CT)
- Retro-cochlear lesion discovered by magnetic resonance imaging (MRI)
- Pregnant women
About this study
Official title: Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss
The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:
- if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
- if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
- to find out which factor from multi-omics data relates to outcomes of SSNHL
- to develop the best prognostics model based on the multi-omics data.
Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral SSNHL | 150 participants will be enrolled with SSNHL involving bilateral ears. | |
| Unilateral SSNHL | 150 participants will be enrolled with SSNHL involving unilateral ear. | |
| Healthy Controls | 100 age-matched healthy controls will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone audiometry (PTA)
Pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz will be measured.
Measured: Baseline, 14 days, 1, 3 and 6 months follow-ups
Secondary outcomes (2)
Speech reception thresholds
Speech Reception Thresholds (SRTs) are employed as a critical outcome measure in clinical trials to assess the lowest level at which speech can be understood. This metric is pivotal for evaluating the efficacy of interventions aimed at improving auditory capabilities or mitigating hearing impairments. SRTs are determined through standardized tests where subjects are required to recognize and repeat spoken words or phrases presented at varying volume levels. The threshold is identified as the minimum intensity at which speech is correctly understood 50% of the time. This quantifiable measure allows for the objective comparison of hearing function before and after interventions, making it a valuable tool in clinical research focused on auditory health and rehabilitation.
Measured: Baseline, 14 days, 1, 3 and 6 months follow-ups
Speech discrimination scores
Speech Discrimination Scores (SDS) are a measure used to assess an individual's ability to correctly understand and repeat spoken words. Unlike Speech Reception Thresholds, which focus on the lowest level of audibility, SDS evaluates the clarity of speech understanding at a comfortable listening level. In clinical settings, a list of phonetically balanced words is presented to the participant at a volume that is easily audible, usually set above their speech reception threshold. The score is calculated based on the percentage of words correctly repeated back by the individual. High SDS indicates good speech clarity recognition, while lower scores may suggest difficulties in speech processing or hearing impairments. SDS is crucial in diagnosing, managing, and treating hearing disorders, providing valuable insights into the functional impact of hearing loss and the effectiveness of auditory rehabilitation strategies.
Measured: Baseline, 14 days, 1, 3 and 6 months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start23 Apr 2024 (estimated)
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Bing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Bing, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365775
- Sponsor's protocol ID
- TJ-IRB20221229
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT06365775
- Acronym / sponsor ID
- TJ-IRB20221229
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Dan BingUniversity, hospital or other
- Study start
- 23 Apr 2024 (estimated)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 15 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 observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:
- if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
- if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
- to find out which factor from multi-omics data relates to outcomes of SSNHL
- to develop the best prognostics model based on the multi-omics data.
Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral SSNHL | – | –150 participants will be enrolled with SSNHL involving bilateral ears. |
| Unilateral SSNHL | – | –150 participants will be enrolled with SSNHL involving unilateral ear. |
| Healthy Controls | – | –100 age-matched healthy controls will be enrolled. |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with SSNHL will be selected from patients diagnosed and treated at Tongji hospital. Participants in healthy controls will be recruited in public from the residents of Wuhan city, China.
Key inclusion criteria (4 listed)
- Age ≥ 4
- Participants with SSNHL: unilateral or bilateral sensorineural hearing loss of > 30 dB HL (decibel) involving at least 3 continuous test frequencies developing within 72 hours
- Healthy controls: people with PTA thresholds of all test frequencies ≤ 20 dB HL and without otologic disease in the last 3 months
- Completed informed consent and promised to finish follow-ups
Key exclusion criteria (5 listed)
- Hearing loss with explicit causes, including noise-induced, Ménière's disease, ototoxicity exposure, mumps infection or history of syphilis infection and so on.
- A history of head trauma or otologic surgery.
- Malformation of temporal bone discovered by computed tomography (CT)
- Retro-cochlear lesion discovered by magnetic resonance imaging (MRI)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pure tone audiometry (PTA)
Time frame: Baseline, 14 days, 1, 3 and 6 months follow-ups
Pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz will be measured.
2 secondary outcomes
Speech reception thresholds
Time frame: Baseline, 14 days, 1, 3 and 6 months follow-ups
Speech discrimination scores
Time frame: Baseline, 14 days, 1, 3 and 6 months follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Related trials for Sudden Sensorineural Hearing Loss
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Not yet recruitingPhase 3
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingPhase 4
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Sensorineural Hearing Loss and Hearing Loss, Sensorineural, run by Dan Bing.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Pure tone audiometry (PTA) (time frame: Baseline, 14 days, 1, 3 and 6 months follow-ups). 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 15 Apr 2024.