CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris, France
Location status: Recruiting
Location contact
Paul Avan, MD
CONTACT
NCT Number: NCT05985473
Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with hearing loss. These individuals have little or no benefit from current hearing aids because ANSD is a continuum of hearing impairments due to synaptic or neural dysfunction in the peripheral and central parts of the auditory pathways, which impairs temporal information processing without necessarily affecting auditory sensitivity. There is a need to find ad-hoc denoising methods, based on the expert knowledge of audiologists, to improve the noise comprehension performance of these patients. Implemented denoising methods, based on artificial intelligence, will also greatly benefit more standard hearing loss cases.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, France
Location status: Recruiting
Paul Avan, MD
CONTACT
Longitudinal study consisting of multiple visits with multiple examinations over a total duration of approximately 3 years per ANSD participant and 1 year per normal hearing participant.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all participants:
For participants with TSNA:
For controls:
Exclusion criteria
For all participants:
audiological measurements
Objective and subjective audiological measurements
Evaluation of the denoising methods REFINED
Time frame: 3 years
Evaluate intelligibility, i.e. the percentage of words correctly repeated, for different speech and noise conditions. Tests will be repeated with and without application of speech enhancement methods to the sound.
Time frame: 3 years
Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.
Time frame: 3 years
Evaluate intelligibility and performance of source localisation for different angles of separation of speech and noises sources
Time frame: 3 years
Evaluate speech perception in noise with phonemes as testing speech
Time frame: 3 years
Assess intelligibility in noise. Vocal tests will be repeated with and without tactile cues.
Time frame: 3 years
c-VEMP assesses the vestibular function through saccular and inferior vestibular nerve function performances. The collected parameters of c-VEMP testing include c-VEMP threshold, the latencies of the initial positivity (p1) and negativity (n1), and the p1-n1 inter-amplitude. We will collect these parameters and assess differences in controls vs. ANSDs.
Time frame: 3 years
This self-assessment involves placing a cursor on a scale ranging from "very uncomfortable to very comfortable" using a scale ranging from 0 to 10.
Time frame: 3 years
This self-assessment involves placing a cursor on a scale ranging from "very inefficient to very efficient" using a scale ranging from 0 to 10.
Contact information is provided by the study sponsor or research team.
Marta Campi, PhD
CONTACT
++33 (0) 1 76 53 51 12
Paul Avan, MD
CONTACT
Institut Pasteur
Industry
Acronym: REFINED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05942261
Deafness, Deafness Neurosensory
Roma, RM, Italy
View Trial DetailsNCT07627971
DFNB1A, Deafness
Boston, Massachusetts, United States
View Trial DetailsNCT05788536
Auditory neuropathy, Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
Los Angeles, California, United States
View Trial DetailsNCT07304024
Age Problem, Auditory Diseases, Central
Aurora, Colorado, United States
View Trial Details