Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sudden Sensorineural Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Sudden. Basic parameters: 4 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Overview
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.
Primary outcome measures
- Pure tone audiometry (PTA) [Time frame: Baseline, 14 days, 1, 3 and 6 months follow-ups]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06365775 · TJ-IRB20221229