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

Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Sensorineural; Sudden Sensorineural Hearing Loss; Hearing Loss, Sudden

• Study Type: Observational
• Enrollment (Estimated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants with SSNHL will be selected from patients diagnosed and treated at Tongji hospital. Participants in healthy controls will be recruited in public from the residents of Wuhan city, China.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Bilateral SSNHL; 150 participants will be enrolled with SSNHL involving bilateral ears.
Unilateral SSNHL; 150 participants will be enrolled with SSNHL involving unilateral ear.
Healthy Controls; 100 age-matched healthy controls will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pure tone audiometry (PTA)	Pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz will be measured.	Baseline, 14 days, 1, 3 and 6 months follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech reception thresholds	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.	Baseline, 14 days, 1, 3 and 6 months follow-ups
Speech discrimination scores	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.	Baseline, 14 days, 1, 3 and 6 months follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variant detection efficiency	The efficiency with which known genetic variants are identified within the targeted regions through capture sequencing of peripheral venous blood samples. This is measured separately for cases and control participants and reported as a percentage (%).	Baseline
Exome coverage	The extent of coverage achieved in the exome regions within peripheral venous blood samples from cases and controls, quantified by the percentage of the exome sequenced at sufficient depth in whole exome sequencing. Results are reported as a percentage (%) for both groups.	Baseline
Genome-wide variant distribution	The distribution and density of genetic variants detected across the entire genome in whole genome sequencing of peripheral venous blood samples. This measure is evaluated for both cases and controls and expressed as the number of variants per megabase (variants/Mb).	Baseline
Head MRI	Assess the integrity of brain tissues, looking for signs of lesions, tumors, or atrophy. This involves qualitative assessments (e.g., presence or absence of abnormalities).	Baseline
Inner Ear MRI	Detailed assessment of the cochlea and vestibular system's anatomy for structural abnormalities, using a qualitative assessment.	Baseline

Collaborators and Investigators

• Sponsor: Dan Bing

Study record dates

Study Major Dates

• Study Start (Estimated): April 23, 2024
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 23, 2026

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Sudden
• Other Study ID Numbers: TJ-IRB20221229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No