Real-time Artificial Intelligence-based Speech Enhancemen... | NCT05985473

Studies
Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement

NCT05985473

Sponsor

Institut Pasteur

Status

Recruiting

Last Update Posted

Mar 15, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Deafness Neurosensory

Interventions

audiological measurements
Objective and subjective audiological measurements
Evaluation of the denoising methods REFINED

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A00140-45	Other Identifier	ID RCB

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2024Actual

Primary Completion Date

Sep 15, 2026Estimated

Completion Date

Sep 15, 2026Estimated

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

Aug 2, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

normal hearing participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests)
ANSD participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests) year 2 : Follow-up Visit 2 (Noise Comprehension Tests) year 3 : Follow-up Visit 3 (Noise Comprehension Tests)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Professionally active adults with a moderate hearing loss	Other		Other: audiological measurements Other: Objective and subjective audiological measurements Other: Evaluation of the denoising methods REFINED

Interventions

Name	Type	Description	Arm Group Labels	Other Names
audiological measurements	Other	audiological measurements	Professionally active adults with a moderate hearing loss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of percentage of words correctly repeated by participants (ANSD and controls)	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.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Auditory Brain Response (ABRs)	Electrical activity of auditoral pathways, from the auditory nerve to the brain, in response to sound stimuli.	3 years
Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For all participants:

Age greater than or equal to 18 years,
French mother tongue,
Have an average tonal hearing loss (calculated according to the BIAP method) < 30 dB HL, on headphones, for each ear,
Be professionally active, not be pre-retired and not be unemployed
Be affiliated with a social security plan,

For participants with TSNA:

- Have degraded comprehension in noise (threshold of Intelligibility in Noise > 3 dB compared to the norm).

For controls:

- Have normal comprehension in noise (Intelligibility in Noise threshold ≤ 3 dB from the norm).

Exclusion Criteria:

For all participants:

Have a conductive or mixed hearing loss, which is when the hearing loss affects both the outer and/or middle ear and the inner ear.
Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear greater than 30 dB,
Have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing (vestibular schwannoma, Meniere's disease, sudden or fluctuating deafness, congenital hypoacusis)
Being under guardianship,
Being deprived of liberty by judicial or administrative decision, or being subject to legal protection.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marta Campi, PhD	Contact	++33 (0) 1 76 53 51 12		marta.campi@pasteur.fr
Paul Avan, MD	Contact	+33 (0)1 76 53 50 94		paul.avan@uca.fr

Overall Officials

Name	Affiliation	Role
Paul Avan, MD	CEntre de Recherche et d'Innovation en Audiologie Humain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CEntre de Recherche et d'Innovation en Audiologie Humaine	Recruiting	Paris			France

ID	Term
D006319	Hearing Loss, Sensorineural
D034381	Hearing Loss

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders