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Sensorineural Hearing Loss clinical trials

View clinical trials related to Sensorineural Hearing Loss.

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NCT ID: NCT04733950 Recruiting - Clinical trials for Sensorineural Hearing Loss

Cochlear Implanted Listening Effort and Hearing Attention

EffICAtt
Start date: December 8, 2021
Phase: N/A
Study type: Interventional

Cochlear implant users perceive mainly sound amplitude modulation cues. Processing of these amplitude modulations can be subject to interferences, so that the perception of a modulation in a target sound can be impaired by a superimposed sound if this sound contains a similar modulation. Such phenomenon, which is observed both in subjects with normal-hearing and in cochlear-implant users, could be explained by difficulties to direct attention to relevant information in complex sound signals. Selective auditory attention also plays a crucial role in speech comprehension in cocktail-party situations where the speech of multiple talkers get mixed at the ear of a listener. Cochlear implant users typically struggle in these cocktail-party situations and report intense listening effort. The present clinical trial aims at evaluating the contribution of selective auditory attention for sound modulations to the listening effort of patients with cochlear implants and of healthy volunteers with normal-hearing during speech perception under cocktail-party-like conditions. Selective auditory attention abilities of patients and controls will be assessed using a psychoacoustical test whereby their ability to detect a target sound amplitude modulation will be measured both in the absence and in the presence of an interfering (i.e. distracting) amplitude modulation occurring in a distant spectral region from that of the target. The effect of this distractor's presence on modulation detection performance will serve as a behavioural index of the subject's auditory attention capacities. The attentional capacity index will then be tested as a predicting factor for the listening effort of the subject during a speech-in-noise consonant identification task. Listening effort will be measured from the pupil dilation response to the presented speech units (pseudowords). This study will enhance our understanding of cochlear implant user's perception and listening effort and will serve as a basis for prognostic tests of listening effort and of implantation success for cochlear implant candidates, based on a simple measurement of auditory attentional abilities.

NCT ID: NCT04610450 Completed - Clinical trials for Sensorineural Hearing Loss

The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.

NCT ID: NCT04462198 Completed - Clinical trials for Sensorineural Hearing Loss

Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

Start date: October 15, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.

NCT ID: NCT04450290 Completed - Clinical trials for Hearing Loss, Sensorineural

Dexamethasone-Eluting Cochlear Implant Electrode

CIDEX
Start date: June 30, 2020
Phase: N/A
Study type: Interventional

A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain a first experience in use of the investigational device in the adult clinical population, and to initially assess tools, techniques and performance outcome measures that may be considered in future clinical studies of similar devices.

NCT ID: NCT04331015 Completed - Clinical trials for Sensorineural Hearing Loss

Artificial Intelligence in Diagnosis of DFNA9

DFNA9
Start date: February 1, 2020
Phase:
Study type: Observational

To study the positive predictive value of Audiogene v.4.0 open source online machine learning tool in accurately predicting DFNA9 (DeaFNess autosomal dominant ninth) as top 3 gene loci in a large series of genetically confirmed c.151C>T,p.Pro51Ser (p.P51S) variant carriers in COCH (coagulation factor C Homology).

NCT ID: NCT04241679 Completed - Clinical trials for Sensorineural Hearing Loss

Auditory Nerve Test System During Vestibular Schwannoma Resection

ANTS
Start date: January 20, 2020
Phase: N/A
Study type: Interventional

The Auditory Nerve Test System (ANTS) is a novel device that stimulates the auditory nerve much like a cochlear implant. The purpose of this study is to demonstrate feasibility of the ANTS during translabyrinthine surgery for vestibular schwannoma resection. If the auditory nerve is kept intact, then the patients will also receive a cochlear implant at the same time potentially alleviating the morbidities caused by a vestibular schwannoma and asymmetric sensorineural hearing loss.

NCT ID: NCT04183361 Enrolling by invitation - Clinical trials for Sensorineural Hearing Loss

ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

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

The aim of the research: Investigate the association of auditory evoked brainstem response characteristics with salivary cortisone concentrations in noise-exposed workers. Purpose of the research: 1. Investigate the magnitude of the amplitudes and latencies of auditory brainstem responses. 2. Investigate the concentration of cortisone in saliva. 3. To investigate the correlation of the characteristics of auditory evoked brainstem potentials with the age of the subjects or the length of work in noise. 4. Investigate the association of salivary cortisone concentration with subjects' age or length of work in noise. 5. Investigate the prevalence of mild, moderate and severe hearing impairment in the 19-35 age group. 6. Investigate the relationship of hearing threshold shift with the age of the subjects or the length of work in noise. 7. To investigate the difference in the characteristics of auditory evoked brainstem potentials and the difference in salivary cortisone concentration between subjects with a bilaterally normal hearing threshold (≤25 dB) at high frequencies and subjects with unilaterally or bilaterally increased hearing threshold (> 25 dB) at high frequencies . 8. Investigate the perceived stress and psychosocial risk factors in the workplace and their relationship to salivary cortisone concentrations. Research Hypothesis: There is an association between the characteristics of auditory evoked brainstem response and salivary cortisone concentrations in noise-exposed workers. Research participants Inclusion criteria: 1. male and female 2. ages 19-35 3. exposure to noise level ≥ 85 dB (A) per week at the workplace 4. work in noise from 1 to 16 years 5. workplace not involving exposure to carbon disulfide or a mixture of organic solvents that have toxic effects on the ear (toluene, xylene and styrene) 6. unilaterally or bilaterally normal otoscopic findings 7. unilaterally or bilaterally tympanogram: peak pressure value ± 50 daPa at 226 Hz with eardrum mobility of 0.3 to 1.3 mL Exclusion criteria: 1. information about an earlier sudden hearing loss 2. information on chronic middle ear inflammation 3. information on ear surgery (except placement of ventilation tubes in the eardrum) 4. information on dizziness associated with hearing loss and noise 5. information on insomnia 6. current use of oral corticosteroids 7. bilaterally found air-bone gap greater than 15 dB

NCT ID: NCT04129775 Completed - Clinical trials for Sensorineural Hearing Loss

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Start date: October 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.

NCT ID: NCT04120116 Completed - Clinical trials for Sensorineural Hearing Loss

FX-322 in Adults With Stable Sensorineural Hearing Loss

Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

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.