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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT05942261 Recruiting - Clinical trials for Deafness Neurosensory

Rehabilitation Methods of Children With Cochlear Implant

MRSI
Start date: May 9, 2023
Phase:
Study type: Observational

The cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. However, the current Italian and international guidelines do not address the issue of rehabilitation and how the different rehabilitation methods should be applied in relation to the different clinical pictures. The aim of this study is therefore to describe which methods are used today in the rehabilitation of deaf children with cochlear implants followed at the Phoniatrics and Speech Therapy service of the A. Gemelli Polyclinic Foundation. The creation of a questionnaire directed to the speech therapist who treats the specific patient is available in order to collect data concerning the characteristics of the setting and the rehabilitation method in relation to the most applied methodologies, i.e. Auditory-verbal therapy, oral-cognitive therapy, bimodal method and the Drežančić method.

NCT ID: NCT05898659 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

Start date: October 17, 2023
Phase: N/A
Study type: Interventional

Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization. Secondary objectives: Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

NCT ID: NCT05849519 Recruiting - Clinical trials for Sudden Sensorineural Hearing Loss

Small Sample,Unicentric,Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss

Start date: February 16, 2022
Phase: Early Phase 1
Study type: Interventional

Sudden sensorineural hearing loss is one of the most common emergencies in otorhinolaryngology, and its incidence is increasing year by year and tends to be younger. At present, the pathogenesis of sudden deafness is not clear and the individual treatment effects vary significantly. In order to break through this specific treatment bottleneck, this project pioneered the clinical application of the co-regulator nicotinamide adenine dinucleotide (NAD+) in the treatment of sudden deafness. Therefore, this project intends to use pure tone audiometry, speech audiometry, tinnitus disability scale THI, tinnitus subjective visual analog score method VAS, ear fullness subjective visual analog score method VAS for data analysis, and explore the safety of coenzyme I for injection on sudden deafness and efficacy assessment.

NCT ID: NCT05821959 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Start date: September 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

NCT ID: NCT05776459 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

Start date: October 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).

NCT ID: NCT05754918 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Brief Summary: Main objective: Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise. Secondary objectives: Comparison of TFS to TnoFS for the perception of musical elements (contour test). Comparison of TFS to TnoFS for speech perception in quiet Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces. Comparison of TFS to TnoFS for the melodic recognition

NCT ID: NCT05709431 Recruiting - Quality of Life Clinical Trials

A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.

CIQoL
Start date: January 12, 2022
Phase:
Study type: Observational

The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants. The CIQoL responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice.

NCT ID: NCT05694039 Recruiting - Clinical trials for Hearing Loss, Sensorineural

A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Background: Deafness is one of the nine potentially modifiable risk factors for dementia simulated by the Lancet dementia Prevention, intervention and Care Committee in 2017. Some studies have found that the risk factors of dementia in deafness system, with the increase of the degree of deafness, the risk of cognitive decline increases, while after long-term wear of hearing aids, the deterioration of immediate and delayed memory is less, and the possibility of cognitive decline slows down. Therefore, it is necessary for us to improve the auditory ability of patients with deafness through auditory intervention, so as to slow down its effect on dementia and reduce the incidence of dementia. At present, auditory intervention methods include hearing aid wearing and cochlear implant. However, there are few studies on cognitive function of presbycusis patients in China, and there is no research on how many years of auditory intervention can effectively slow down the incidence of dementia in presbycusis patients with MCI. Therefore, we intend to conduct a prospective cohort study on the changes of cognitive function of presbycusis under hearing aid intervention.

NCT ID: NCT05670158 Recruiting - Clinical trials for Sensorineural Hearing Loss

Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss

PERILOTO
Start date: December 7, 2023
Phase: N/A
Study type: Interventional

Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Although the mechanisms involved in the residual audition loss remain unknown, animal experiments suggest the role of inflammatory or immune reaction in the cochlea. The goal of this project is to search in the perilymph (a fluid which fills the scala vestibuli and scala tympani of the cochlea) some predictive biomarkers of the residual hearing loss using modern proteomics and immunological techniques. A parallel search for blood biomarkers of post-implantation residual hearing loss and for molecular and cellular evidences of immune response to cochlear implantation will be performed. The study will recruit 50 subjects-candidates for cochlear implantation surgery; 30 normally hearing individuals eligible for other types of otological interventions will form a control group. For all the participants blood samples will be collected and preserved. In addition, the perilymph sampling will be performed during cochlear implantation surgery. This project relies on the calculation that from 50 patients post-cochlear implantation, 15 patients will form a group with maintained residual hearing and 15 will display delayed hearing loss. For these 30 subjects together with the control group the blood biomarkers search will be performed. For the group of implanted patients, the follow-up will last for 12 months with 6 visits in total : - the inclusion visit V0 during which the study will be presented and the consent form will be signed - the surgery visit V1 with blood sample and perilymph collection - the activation visit V2, 1 month ± 1 week after V1, visit V3 3 months ± 7 days after V1, V4 6 months ± 7 days after V1, V5 12 months ± 1 month after V1. During each of this visit blood sampling will be performed. For the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments: - the inclusion visit V0 during which the study will be presented and the consent form will be signed - the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.

NCT ID: NCT05641155 Recruiting - Clinical trials for Hearing Impairment, Sensorineural

A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.

SASC
Start date: June 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that intend to maximize hearing performance benefits within technical requirements. This study is exploratory in nature and will achieve its objectives through ongoing review and adjustment of device parameters and fitting