NCT06691087

Brief Summary

The aim of the ETERNEL project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. This will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. The more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. In this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2025Nov 2028

First Submitted

Initial submission to the registry

October 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

October 14, 2024

Last Update Submit

March 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group,

    3-hours

Secondary Outcomes (3)

  • Characterisation of the dissimilarity between pairs of stimuli measured by a continuous perceptual scale

    3-hours

  • Evaluation of the perceived loudness level of a set of stimuli, measured using scales of magnitude.

    3-hours

  • Comparison between the results of speech audiometry in noise, i.e number of words correctly repeated, with native settings versus settings minimising the discomfort of salient sounds for each participant with hearing loss.

    up to 24 months

Study Arms (2)

Normal Hearing participants

ACTIVE COMPARATOR
Behavioral: Influence of the parameters of the sound timbre on the perception of a soundBehavioral: Complex sound scene comprehension test

Hearing-impaired with hearing aids

EXPERIMENTAL
Behavioral: Influence of the parameters of the sound timbre on the perception of a soundBehavioral: Complex sound scene comprehension testBehavioral: Complex sound scene comprehension test with hearing aids

Interventions

The experiment consists of evaluating the sound level of n complex stimuli, then equalising them in loudness, in order to measure a loudness curve in function of timbre descriptors. The stimuli will then be listened to again in pairs. The task is there to compare the stimuli using a VAS to indicate how different the two sounds are.

Hearing-impaired with hearing aidsNormal Hearing participants

The experiment consists in identifying the parameters of the sound timbre that most disturb the understanding of complex sound scenes, by asking the participants to identify sounds whose timbre has been modified.

Hearing-impaired with hearing aidsNormal Hearing participants

The experiment will be identical to intervention 2. This time, the modification of the stimulus timbres will focus on the most problematic dimensional modifications, i.e. those where the difference between normal-hearing and hearing-impaired listeners is greatest. We will then modify the signal processing parameters of the hearing aid simulator (for example, the size of the averaging window or the gain balance of the filters), to observe their impact on the salience of certain stimuli.

Hearing-impaired with hearing aids

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all participants:
  • Age between 60 and 75
  • Native French speaker
  • Have given their consent to take part in the study.
  • Declare that they have an active social life or hobbies that stimulate their cognitive abilities
  • Have a MOCA score above 26
  • No tympano-ossicular dysfunction.
  • Voice in noise audiometry results showing normal results.
  • For participants with impaired hearing :
  • Pure tone audiometry showing audiograms of type N3 or N4 and symmetrical between the two ears.
  • Report having experienced problems with abnormally prominent sound.
  • For participants with normal hearing:
  • \- Pure tone audiometry showing audiograms with losses of less than 30 dBHl.

You may not qualify if:

  • Be under guardianship or curatorship,
  • Be deprived of liberty by judicial or administrative decision, or be under legal protection.
  • Bear the consequences of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CeRIAH

Paris, France

RECRUITING

MeSH Terms

Interventions

Hearing Aids

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Paul Avan

    CERIAH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Armand Schwarz

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

November 15, 2024

Study Start

April 22, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations