Clinical trial NCT06365775: Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
Official title: Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sudden Sensorineural Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Sudden
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pure tone audiometry (PTA)
timeFrame: Baseline, 14 days, 1, 3 and 6 months follow-ups
Secondary outcomes:
measure: Speech reception thresholds
timeFrame: Baseline, 14 days, 1, 3 and 6 months follow-ups
measure: Speech discrimination scores
timeFrame: Baseline, 14 days, 1, 3 and 6 months follow-ups
Other outcomes:
measure: Variant detection efficiency
timeFrame: Baseline
measure: Exome coverage
timeFrame: Baseline
measure: Genome-wide variant distribution
timeFrame: Baseline
measure: Head MRI
timeFrame: Baseline
measure: Inner Ear MRI
timeFrame: Baseline
Locations:
Study officials:
References: