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

Hearing Loss, Sensorineural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365775
• Other study ID #: TJ-IRB20221229
• Status: Not yet recruiting
• Start date: April 23, 2024
• Est. completion date: November 23, 2026

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 23, 2026
• Est. primary completion date: November 23, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden
• Sudden Sensorineural Hearing Loss

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dan Bing

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Inner Ear MRI	Detailed assessment of the cochlea and vestibular system's anatomy for structural abnormalities, using a qualitative assessment.	Baseline
Primary	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	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
Secondary	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