Clinical Trials Logo

Deafness clinical trials

View clinical trials related to Deafness.

Filter by:

NCT ID: NCT04888143 Completed - Profound Deafness Clinical Trials

Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.

Algo Fréq
Start date: June 8, 2020
Phase: N/A
Study type: Interventional

360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment. Cochlear implants are indicated in severe to profound deafness in some cases. The principle of the cochlear implant is to directly stimulate the fibres of the auditory nerve via electrodes inserted into the cochlea. It stimulates the auditory nerve and sends electrical impulses to the brain where they are interpreted as sounds. The steps in hearing rehabilitation are surgical placement of the cochlear implant, activation, and follow-up adjustments. There is no formal consensus on the exact adjustment procedures during activation or follow-up, but principles are followed depending on the cochlear implant adjustment centers (jack). All centers focus on sound intensity adjustments to achieve the goals of tonal audiometry in open-field silence with cochlear implant alone between 20 and 40 db (30 db most frequently). However, it is common practice to observe that this means of assessment does not really represent the performance of the individual because hearing a sound does not mean that someone will be able to recognize it and interpret it. Some of the patients who achieve these goals have difficulty hearing well in a noisy environment. Speech audiometry in silence and especially in noise would be a better reflection of patient needs. Bimodal hearing is having a cochlear implant and a contralateral hearing aid. In cochlear implants, having bimodal binaural hearing improves the patients ability to understand speech in silent and noisy contexts. It should thus be considered when a second cochlear implant is not indicated in the contralateral ear. It has been shown that intelligibility and musical perception are altered when the frequency allocations are different from the manufacturer's default frequency allocations. The possible redundancy between the acoustic and electrical information on the contralateral ear can lead to metallic distortion of the voice, which is perceived as less natural. This is due to a different stimulation of the cochlear tonotopic zones concerning conversational frequencies, between the implanted side and the device side. However, the frequency distribution is not subject to adjustment in current practice. A modification of the frequency distribution is possible on cochlear implants, which could improve the intelligibility and comfort of the implanted patient. This working hypothesis will be studied, and a simple protocol for frequency reallocation of the cochlear implant will be developed to optimize the daily hearing performance of the implanted patients. An evolutionary algorithm will be used. The search for new adjustment solutions will be carried out within the safety limits imposed by the adjusters (detection and comfort loudness threshold).

NCT ID: NCT04875117 Completed - Fatigue Clinical Trials

Fatigue and Hearing Loss.

Start date: April 4, 2018
Phase:
Study type: Observational

An intervention group and a control group will complete a battery of questionnaires at four time points to investigate the impact of first-ever hearing aid fitting on fatigue and associated variables. The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care.

NCT ID: NCT04862572 Completed - Hearing Loss Clinical Trials

Investigating Disinhibitory Brain Mechanism in Tinnitus and Hearing Loss

IGNITE
Start date: August 9, 2021
Phase: N/A
Study type: Interventional

Tinnitus, the perception of sound in the absence of an external acoustic stimulus. Tinnitus is often perceived inside the head rather than the ear and is a common condition with a prevalence estimated between 10 and 15% in adults. Between 1 and 3% of this population are having a significant impact on their quality of life. Despite its high prevalence, the underlying mechanisms of tinnitus still remain unclear. The majority of tinnitus cases associated with some degree of hearing loss, making hearing loss the biggest risk factor for tinnitus. Recently, it has been suggested that hearing deficits, such as speech-in-noise difficulty, can exist in the absence of any overt hearing loss within the audiometric range (0.125-8 kHz). This is referred to as "hidden hearing loss" and has been suggested to be associated with hearing loss at above-audiometric (> 8 kHz) frequencies. This project is aimed at studying the underlying mechanisms of tinnitus and the possible relation with overt or hidden hearing loss. Specifically, the investigators want to test the hypothesis that tinnitus is caused by maladaptive plasticity arising as a result of auditory input deprivation. This idea is supported by the finding that tinnitus may disappear when the hearing, and thus auditory input, recover. Disruptions at lower levels of the auditory pathway could lead to alterations in synaptic transmission and neurotransmitter release in more central regions of the auditory system (e.g., in the auditory cortex). This may create an imbalance between neuronal excitation and inhibition, and re-routing of auditory pathways, leading to abnormal neural excitability and connectivity. In this study, the investigators question whether auditory cortex disinhibition is specifically related to tinnitus, or is a consequence of hearing loss. To answer this question, the investigators propose to conduct a study that aims to investigate the inhibition mechanism by quantifying GABA concentration level, neural activity and functional connectivity strength of auditory cortex using non-invasive imaging techniques, namely Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI). The investigators expected to possibly provide a tinnitus biomarker, and this may help to direct future treatments.

NCT ID: NCT04845412 Completed - Hearing Loss Clinical Trials

Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic Mothers

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

In this study, the investigators have aimed to investigate whether GDM is a risk factor for hearing impairment in newborns. To the investigators knowledge, this study is the first prospective, controlled study on this subject.

NCT ID: NCT04823494 Completed - Clinical trials for Hearing Loss, Sensorineural

Wear-Time Trial for Self-Fitting Hearing Aid

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

This document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (GN) self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.

NCT ID: NCT04794179 Completed - Hearing Impairment Clinical Trials

CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers

Start date: November 6, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of the Naida Link CROS device on speech understanding in challenging listening situations and on the quality of life in unilateral CI recipients and their frequent communication partners. We hypothesize that: 1. Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions 2. Use of the CROS device will lead to positive changes in ratings on Quality of Life measures for (i) unilateral CI recipients, and (ii) their frequent communication partners A frequent communication partner (FCP) is an individual (a family member, or a friend, or a care taker, or a significant other, or a colleague, etc.) who has at least two hours of in-person interactions with the CI recipient every week.

NCT ID: NCT04761926 Completed - Clinical trials for Hearing Loss, Conductive

Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The study is a prospective, multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019. Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics. The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.

NCT ID: NCT04754477 Completed - Hearing Loss Clinical Trials

Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.

NCT ID: NCT04691830 Completed - Clinical trials for Hearing Impaired Children

Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children

Start date: February 19, 2019
Phase: N/A
Study type: Interventional

Prosody is the melody and rhythm of speech, it is used to refer to the supra segmental aspects of speech including pitch, loudness and duration. Variations in these features achieve different prosodic functions and are perceived by the listener as meaningful changes. The role of prosody in language acquisition and effective communication is documented in research. Nevertheless, prosodic intervention in children with hearing impairment received less attention compared to other speech and language areas. The aim of this study is to adapt the "prosody treatment program", an evidence based rehabilitation program, and to detect the efficacy of its activities in improving the prosodic skills of Egyptian hearing impaired children. The "prosody treatment program" is an evidence-based practice targeting receptive and expressive prosodic skills in addition to speech production, intelligibility, pragmatics and phonology. The program is applied using a systematic approach of providing cues following the principles adapted from dynamic temporal and tactile cueing (DTTC) for speech motor learning to help accelerate the child's learning of the prosodic skills targeted in this program. The program was translated to Arabic and adapted to be suitable for the Egyptian children.

NCT ID: NCT04663022 Completed - Deafness Clinical Trials

Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

PSIC-TSA
Start date: December 1, 2020
Phase:
Study type: Observational

An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated Autism Spectrum Disorders. Our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism Spectrum Disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?