NCT07675941

Brief Summary

In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. These assessment situations are not representative of the functional difficulties encountered by people with hearing loss or Auditory Processing Disorder in their daily lives. In real life, "soundscapes" are diverse. Hearing assessment and rehabilitation should include the child's everyday environments as well as their lifestyle habits. The Immersion 360 System (Virtual reality system) was developed specifically to virtually reproduce complex everyday sound experiences with realistic noise types and sound presentation conditions, enabling the assessment of auditory perception under test conditions similar to those encountered in daily life. Some of the sound environments offered by this innovative system have been standardized for adults. No standards exist for children, and we have limited knowledge regarding the development of speech perception skills in noise during childhood and adolescence. It seems essential to measure the age-related development of speech perception in realistic sound environments in order to establish reference data for children and adolescents. This work will, through functional assessments of the auditory system and linguistic tests (speech perception in noise), provide a better understanding of the functional development of the central auditory system for speech perception in noise. The results collected from normo-hearing individuals in the age groups of interest will provide a clinical baseline for comparison with patients of the same age.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress9%
Jul 2026Jul 2027

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of correct word identification

    2 hours

Secondary Outcomes (3)

  • average of auditory data

    2 hours

  • difference between a natural sound environment vs. a SpeechInNoise environment

    2 hours

  • Difference between scores obtained with the 360 Immersion System and scores from the literature

    2 hours

Study Arms (5)

Children aged 7

Other: Système Immersion 360

Children aged 8 to 9 years

Other: Système Immersion 360

Children aged 10 to 11 years

Other: Système Immersion 360

Children aged 12 to 13 years

Other: Système Immersion 360

Children aged 14 to 15 years

Other: Système Immersion 360

Interventions

The children will be placed at the center of the 360 Immersion System. The four sound environments (school cafeteria: loud and constant noise; playground: fluctuating noise; street: ambient sound without speech; multi-voice noise or SpeechInNoise) will be played one after the other, and two lists of 20 sentences will be presented to the child in each environment, without the possibility of repetition, at the actual signal-to-noise ratio. The child will have to repeat the sentences. The "cafeteria," "playground," and street recordings will be played again to the child, with a different signal-to-noise ratio, making it more difficult for the child to perceive speech. The session lasts approximately 45 minutes, but to limit fatigue for our young participants, a 15-minute break will be offered. Children can also request a break themselves if they become tired. A certificate will be awarded to each of our healthy volunteers.

Children aged 10 to 11 yearsChildren aged 12 to 13 yearsChildren aged 14 to 15 yearsChildren aged 7Children aged 8 to 9 years

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 7 to 15 with normal hearing

You may qualify if:

  • Children with normal hearing (average hearing thresholds at 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz less than 20 dB)
  • Be between 7 and 15 years old
  • Be a native French speaker, without bilingualism
  • Have typical development, as assessed by a school level corresponding to their age;
  • No objection from at least one of the two legal guardians
  • Legal guardian registered with social security
  • Able to understand instructions and information provided

You may not qualify if:

  • Inability of the child to respond to tests
  • Abnormal hearing thresholds
  • Speech disorder treated by speech therapist
  • Inability to understand instructions / to respond to tests
  • Neurological conditions
  • Multiple disabilities
  • Ongoing treatment that may affect alertness
  • Unstable ADHD
  • History of tympanic surgery for chronic otitis media
  • Legal impossibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASEI, Unité Ressources Audition

Ramonville-Saint-Agne, 31522, France

Location

Study Officials

  • Aurore BERLAND

    ASEI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Noëlle CALMELS, Dr

CONTACT

Aurore BERLAND

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations