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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT06467526 Not yet recruiting - Sudden Hearing Loss Clinical Trials

Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

Sudden sensorineural hearing loss (SSNHL) is diagnosed when there's a sudden drop in hearing of at least 30 decibels across three consecutive frequencies, emerging within up to 72 hours. In clinical settings, steroids are the predominant treatment for SSNHL. However, the outcomes for patients undergoing steroid therapy for SSNHL can differ substantially. Moreover, a systematic review of randomized clinical trials has found no conclusive evidence pinpointing an effective treatment for SSNHL. Hydroxychloroquine, a derivative of chloroquine, is a medication that has gained attention for its potential role in modulating the immune response. We aim to see if hydroxychloroquine could augment hearing recovery in SSNHL under steroid treatment and to evaluate the safety of hydroxychloroquine in the treatment of SSNHL patients. We plan to enroll 80 SSNHL patients who received oral steroid therapy and randomize them into an experimental group (hydroxychloroquine with prednisolone, 40 patients) and a control group (prednisolone, 40 patients). The primary endpoint will be the change in pure tone audiogram (PTA) in the affected ear from screening until 3 months. The secondary endpoints will be the change in word recognition score and the change in bilateral tinnitus severity after treatment. Any side effects will be recorded to ensure the safety of this clinical trial.

NCT ID: NCT06453343 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

BULLS-I
Start date: July 2024
Phase: N/A
Study type: Interventional

This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.

NCT ID: NCT06437054 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss

Start date: February 15, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

NCT ID: NCT06424262 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)

DETECT
Start date: June 2024
Phase: N/A
Study type: Interventional

This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.

NCT ID: NCT06420921 Not yet recruiting - Clinical trials for Cochlear Hearing Loss

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

MIRACLE
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with cochlear implant(s). The measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis. Researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment. Participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement.

NCT ID: NCT06377215 Not yet recruiting - Aging Clinical Trials

Understanding Aided Speech Perception in Noise

Start date: April 15, 2024
Phase:
Study type: Observational

The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.

NCT ID: NCT06370351 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

AUDIOGENE
Start date: April 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

NCT ID: NCT06365775 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

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

Start date: April 23, 2024
Phase:
Study type: 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: - 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.

NCT ID: NCT06355102 Not yet recruiting - Tinnitus Clinical Trials

The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics

Start date: April 15, 2024
Phase:
Study type: Observational

The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are: - What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL? - Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients? Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis. Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time.

NCT ID: NCT06354010 Not yet recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis

SONG
Start date: May 2024
Phase:
Study type: Observational

The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.