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Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss

D

Dan Bing

Status

Not yet enrolling

Conditions

Hearing Loss, Sudden
Sudden Sensorineural Hearing Loss
Hearing Loss, Sensorineural

Study type

Observational

Funder types

Other

Identifiers

NCT06365775
TJ-IRB20221229

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

4 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Bilateral SSNHL
Description:
150 participants will be enrolled with SSNHL involving bilateral ears.
Unilateral SSNHL
Description:
150 participants will be enrolled with SSNHL involving unilateral ear.
Healthy Controls
Description:
100 age-matched healthy controls will be enrolled.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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