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

NCT ID: NCT06365775

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2026-11-23

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral SSNHL

150 participants will be enrolled with SSNHL involving bilateral ears.

No interventions assigned to this group

Unilateral SSNHL

150 participants will be enrolled with SSNHL involving unilateral ear.

No interventions assigned to this group

Healthy Controls

100 age-matched healthy controls will be enrolled.

No interventions assigned to this group

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dan Bing

OTHER

Sponsor Role: lead

Responsible Party

Dan Bing

associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

TJ-IRB20221229

Identifier Type: -

Identifier Source: org_study_id