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

Not yet recruiting

• Conditions: Hearing Loss, Sensorineural; Hearing Loss, Sudden; Sudden Sensorineural Hearing Loss

• Registration Number: NCT06365775
• Lead Sponsor: Dan Bing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Study Start: 2024-04-23
• Primary Completion: 2026-11-23
• Study Completion: 2026-11-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pure tone audiometry (PTA)	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 Outcome Measures

Name	Time	Method
Speech reception thresholds	Baseline, 14 days, 1, 3 and 6 months follow-ups	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.
Speech discrimination scores	Baseline, 14 days, 1, 3 and 6 months follow-ups	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.