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

23. června 2026 aktualizováno: University Hospital, Toulouse

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

150

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Francie
      • Ramonville-Saint-Agne, Francie, 31522
        • ASEI, Unité Ressources Audition

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Children aged 7 to 15 with normal hearing

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Children aged 7
Jiný: Système Immersion 360

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 8 to 9 years
Jiný: Système Immersion 360

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 years
Jiný: Système Immersion 360

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 12 to 13 years
Jiný: Système Immersion 360

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 14 to 15 years
Jiný: Système Immersion 360

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
percentage of correct word identification
Časové okno: 2 hours
2 hours

Sekundární výstupní opatření

Měření výsledku
Časové okno
average of auditory data
Časové okno: 2 hours
2 hours
difference between a natural sound environment vs. a SpeechInNoise environment
Časové okno: 2 hours
2 hours
Difference between scores obtained with the 360 Immersion System and scores from the literature
Časové okno: 2 hours
2 hours

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Hospital, Toulouse

Spolupracovníci

Association act care educate include

Vyšetřovatelé

  • Vrchní vyšetřovatel: Aurore BERLAND, ASEI

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. července 2027

Dokončení studie (Odhadovaný)

1. července 2027

Termíny zápisu do studia

První předloženo

23. června 2026

První předloženo, které splnilo kritéria kontroly kvality

23. června 2026

První zveřejněno (Aktuální)

30. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • RC31/26/0048

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Système Immersion 360

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