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Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age (SI 360)

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Noise Exposure
Child
Normal Hearing

Treatments

Other: Système Immersion 360

Study type

Observational

Funder types

Other

Identifiers

NCT07675941
RC31/26/0048

Details and patient eligibility

About

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.

Full description

This is a single-center, descriptive, cross-sectional, preliminary study to describe the age-related distribution of speech perception scores in noise. The study will be non-randomized and conducted on healthy, hearing minor volunteers. The inclusion period will be 12 months, with each participant spending 1.5 to 2 hours in the study.

Enrollment

150 estimated patients

Sex

All

Ages

7 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

150 participants in 5 patient groups

Children aged 7
Treatment:
Other: Système Immersion 360
Children aged 8 to 9 years
Treatment:
Other: Système Immersion 360
Children aged 10 to 11 years
Treatment:
Other: Système Immersion 360
Children aged 12 to 13 years
Treatment:
Other: Système Immersion 360
Children aged 14 to 15 years
Treatment:
Other: Système Immersion 360

Trial contacts and locations

1

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Central trial contact

Marie-Noëlle CALMELS, Dr; Aurore BERLAND

Data sourced from clinicaltrials.gov

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