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Cochlear Implantation clinical trials

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NCT ID: NCT06375278 Not yet recruiting - Hearing Loss Clinical Trials

Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1. Is mild therapeutic hypothermia safe for use during cochlear implantation? 2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation? Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).

NCT ID: NCT06040892 Recruiting - Clinical trials for Cochlear Implantation

Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

KidTrain
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life. The ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI. The investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training. The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations. Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening). Based on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie & Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.

NCT ID: NCT05917496 Not yet recruiting - Clinical trials for Cochlear Implantation

Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation

ACLEIC
Start date: July 2024
Phase:
Study type: Observational

The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech. The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.

NCT ID: NCT05547113 Recruiting - Clinical trials for Cochlear Implantation

Vestibular Function in Cochlear Implant Patients

Start date: January 11, 2020
Phase:
Study type: Observational

A hearing loss is condition which significantly affects the quality of life. The prevalence of the hearing disorders is relatively high due to many conditions which may result in a deafness. In those cases where hearing aids are not a sufficient solution to these difficulties, cochlear implantation is the standard treatment. It has been more than 30 years since the first implantation in the Czech Republic. These days it is common surgical procedure for adults and even children and it replaces, at least in part, the function of the hair cells that are no longer able to stimulate the primary auditory neurons.. Recent studies have reported that cochlear implant does not affect only hearing, but also other functions of the inner ear - the vestibular system resulting in stability and spatial orientation. Postural control is provided by coordination of movement strategies and sensory functions. If one ore more of these components are compromised postural instability appears. Instability is one of the most common causes of reduced quality of life. The deaf are characterized by their compensatory mechanisms, where visual system dominates over somatosensory and vestibular. After the cochlear implantation the postural behavior and compensations are changing apparently. The investigators assume that these mechanisms can be affected by vestibular rehabilitation. The purpose of this projet, will be to evaluate whether electrical stimulation of the eighth cranial nerve also affects vestibular functions and determine if the stimulaton changes postural stability and created compensations.

NCT ID: NCT05122364 Not yet recruiting - Hearing Loss Clinical Trials

Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital

Start date: February 2022
Phase: N/A
Study type: Interventional

Design online program for language sessions for cochlear implanted children in arabic and monitor its validity and reliability to improve language outcome

NCT ID: NCT04906135 Recruiting - Clinical trials for Cochlear Implantation

Auditory Neural Function in Implanted Patients With Usher Syndrome

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Usher syndrome (USH) causes extensive degeneration in the cochlear nerve (CN), especially in CN fibers innervating the base of the cochlea. As the first step toward developing evidence-based practice for managing implant patients with USH, this study evaluates local neural health, as well as the neural encoding of temporal and spectral cues at the CN in implanted patients with USH. Aim 1 will determine local CN health in patients with USH by assessing the sensitivity of the electrically evoked compound action potential to changes in interphase gap and pulse polarity. Aim 2 will determine group differences in neural encoding of temporal and spectral cues at the CN between patients with USH and patients with idiopathic hearing loss. Aim 3 will use supervised machine learning techniques to develop an objective tool for assessing the electrode-neuron interface at individual electrode locations.

NCT ID: NCT04832373 Completed - Clinical trials for Cochlear Implantation

Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2

H2R2
Start date: September 17, 2021
Phase: N/A
Study type: Interventional

The quality of the rehabilitation of deafness in children with cochlear implantation is a major prognostic factor for the outcome on speech comprehension and oral expression. This rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and by a speech therapist located near the child's home. The multi-weekly sessions represent a constraint for the child and his parents. Complementary training work at home would make it possible to balance the equity in the distribution of care in the territory, and should promote the progress of the child, who is more inclined to use a tool available at home.

NCT ID: NCT04192968 Active, not recruiting - Clinical trials for Cochlear Implantation

Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results

ImplantHear3
Start date: January 13, 2020
Phase:
Study type: Observational

The objective of the study is to compare the responses recorded with automated cortical auditory evoked potentials, of children who had one or two cochlear implants for 3 years, and the results of the speech therapy assessment. 24 patients in the main ImplantHear3 study presented with disappointing language development or poor cortical responses. These patients will be followed up once a year, during a visit scheduled for the usual care, until 6 years post-implant, in order to make it possible to objectify the quality of the auditory rehabilitation received by the child.

NCT ID: NCT03958006 Completed - Clinical trials for Vestibular Schwannoma

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Start date: December 5, 2018
Phase: N/A
Study type: Interventional

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

NCT ID: NCT03950375 Completed - Clinical trials for Cochlear Implantation

Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

R-PO18155
Start date: December 18, 2018
Phase:
Study type: Observational

The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.