NCT06365775
Not yet recruiting
Not Applicable
Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Dan Bing0 sites400 target enrollmentApril 23, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sudden Sensorineural Hearing Loss
- Sponsor
- Dan Bing
- Enrollment
- 400
- Primary Endpoint
- Pure tone audiometry (PTA)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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). 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.
Investigators
Dan Bing
associate professor
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Speech reception thresholds(Baseline, 14 days, 1, 3 and 6 months follow-ups)
- Speech discrimination scores(Baseline, 14 days, 1, 3 and 6 months follow-ups)
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