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

NCT06365775 | Not Yet Recruiting

• 1 other identifier: TJ-IRB20221229
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sudden Sensorineural Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Sudden

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Speech reception thresholds

  Baseline, 14 days, 1, 3 and 6 months follow-ups

• Speech discrimination scores

  Baseline, 14 days, 1, 3 and 6 months follow-ups

Other Outcomes (5)

• Variant detection efficiency

  Baseline

• Exome coverage

  Baseline

• Genome-wide variant distribution

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dan Bing: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood sample.

MeSH Terms

Conditions

Hearing Loss, Sudden; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: April 15, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04