FX-322 in Adults With Stable Sensorineural Hearing Loss
NCT04120116
Ear Diseases, Hearing Disorders
Fresno, California, United States
View Trial DetailsNCT Number: NCT06365775
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.
Trial opening soon.
Get Notified4 year–65 year
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 14 days, 1, 3 and 6 months follow-ups
Pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz will be measured.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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 (%).
Time frame: Baseline
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.
Time frame: Baseline
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).
Time frame: Baseline
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).
Time frame: Baseline
Detailed assessment of the cochlea and vestibular system's anatomy for structural abnormalities, using a qualitative assessment.
Dan Bing
Other
Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss
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