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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT04131439 Recruiting - Clinical trials for Hearing Loss, Sensorineural

CT and MRI for Pre-Operative Cochlear Imaging

Start date: December 1, 2019
Phase:
Study type: Observational

This study investigates the role of the preoperative computed tomography (CT) and magnetic resonance imaging (MRI) before cochlear implants and their role in selecting suitable patients for surgery.

NCT ID: NCT04130113 Recruiting - Clinical trials for Hearing Loss, Cochlear

Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Start date: September 18, 2019
Phase: N/A
Study type: Interventional

Sixty (60) subjects between the ages of 7 months and 5 years, 11 months will be implanted with the MED-EL SYNCHRONY/SYNCHRONY 2 Cochlear Implant System. All subjects will demonstrate a severe to profound sensorineural hearing loss (SNHL) in the high frequencies (2000 Hz and above) and insufficient functional access to sound with appropriately fit amplification and aural habilitation. Additionally, subjects implanted under 12 months of age will demonstrate a severe to profound sensorineural hearing loss, defined by a 3-frequency Pure Tone Average (PTA) of ≥ 70 dB HL at 500, 1000 and 2000 Hz, while subjects 12 months to 5 years, 11 months of age will demonstrate a mild to profound sensorineural hearing loss in the low frequencies, defined by a 3-frequency PTA of ≥ 25 dB HL at 500, 1000 and 2000 Hz. For the purposes of this study, insufficient functional access to sound for children who lack the requisite language to complete open-set word recognition testing will be based on the LittlEARS Auditory Questionnaire (LEAQ) and defined as a Total Score below the expected value for normal hearing (NH) children of the same chronological age1. For children with the requisite language to complete MLNT/LNT testing, insufficient functional access to sound will be defined by word recognition scores of ≤ 60% on the MLNT/LNT. Subjects will be followed for twelve (12) months following initial activation of the audio processor, with post-operative evaluations occurring at device.

NCT ID: NCT04108598 Recruiting - Clinical trials for Sensorineural Hearing Loss

The SeaSHeL National Prospective Cohort Study

SeaSHeL
Start date: October 7, 2019
Phase:
Study type: Observational

Each year, approximately 15,000 people in the United Kingdom experience sudden loss of hearing that is sensorineural in nature. In the majority of cases, the cause is unknown despite investigation, and these cases are termed idiopathic 'sudden onset sensorineural hearing loss' (SSNHL). Treatment options for idiopathic SSNHL mainly include steroid treatments, with considerable limitations in their effectiveness and evidence base. There are a number of new treatments being developed for idiopathic SSNHL based upon recent discoveries in underlying molecular mechanisms. These treatments require rigorous testing in clinical trials before they can become available for clinical use. To allow for such trials to be run effectively, there is an urgent need for information on patient numbers, geographical distribution, demographics, patient and treatment pathways, as well as outcomes. This study proposes to collect these data through an ENT trainee and Audiologist led nationwide prospective cohort study of adult patients presenting with SSNHL within the National Health Services (NHS). The study will take place at 97 NHS sites across England with Ear, Nose, and Throat (ENT) and Audiology services. Data once collected will be analysed to: 1. Establish the patient pathway for patients presenting with SSNHL in the NHS 2. Develop a tool that will help predict recovery for patients with idiopathic SSNHL. 3. Establish the impact of idiopathic SSNHL on people's quality of life.

NCT ID: NCT04102215 Recruiting - Clinical trials for Sensorineural Hearing Loss

The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

ARCI25
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.

NCT ID: NCT04070937 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well. The purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.

NCT ID: NCT04066270 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

In 2014 radiological lesions at one or more semicircular canals (SCC) were described using CT & MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.

NCT ID: NCT03996824 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

TREATGENE
Start date: February 19, 2019
Phase:
Study type: Observational

Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models. This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.

NCT ID: NCT03848338 Recruiting - Clinical trials for Hearing Loss, Cochlear

Electrocochleography Function for Monitoring Residual Hearing

ECochG
Start date: January 24, 2019
Phase: N/A
Study type: Interventional

This trial is a pilot study to assess the feasibility of using Electrocochleography recorded from a cochlear implant intra-operatively in real time to monitor the progress of its insertion. Correlation between: 1. Observed changes in this signal during surgery and residual hearing loss post-operatively and 2. Recordings of this signal post-operatively and actual pure tone audiometry results will also be assessed.

NCT ID: NCT03715569 Recruiting - Clinical trials for Hearing Loss, Sensorineural

CNS Infections Effect on the Inner Ear

Start date: December 1, 2017
Phase:
Study type: Observational

Study on patients with CNS infections.

NCT ID: NCT03700268 Recruiting - Clinical trials for Deafness; Perception

Programming Cochlear Implant With Artificial Intelligence

CI_AI
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'Artificial Intelligence programming'. The investigators want to compare, objectify, and control this new mode of programming. The study is planned over 4 years, in order to test, randomized, 15 subjects with manual programming and 15 other subjects with Artificial Intelligence programming. To test the performance of Cochlear Implant patients, audiological, language auditory perception and questionnaire tests will be presented. This research aims to determine the contribution and results of Artificial Intelligence programming.