An observational study in Sudden Sensorineural Hearing Loss, Hearing Loss, Sensorineural and Hearing Loss, Sudden, sponsored by Dan Bing. Not yet recruiting. Open to participants aged 4 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Dan Bing · Observational
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:
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.
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.
Exclusion Criteria:
150 participants will be enrolled with SSNHL involving bilateral ears.
150 participants will be enrolled with SSNHL involving unilateral ear.
100 age-matched healthy controls will be enrolled.
Pure tone audiometry (PTA)
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
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
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, 14 days, 1, 3 and 6 months follow-ups
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 (%).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline
Inner Ear MRI
Detailed assessment of the cochlea and vestibular system's anatomy for structural abnormalities, using a qualitative assessment.
Time frame: Baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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