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

23 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

150

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Children aged 7 to 15 with normal hearing

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Children aged 7

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

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

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

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

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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
percentage of correct word identification
Ramy czasowe: 2 hours
2 hours

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
average of auditory data
Ramy czasowe: 2 hours
2 hours
difference between a natural sound environment vs. a SpeechInNoise environment
Ramy czasowe: 2 hours
2 hours
Difference between scores obtained with the 360 Immersion System and scores from the literature
Ramy czasowe: 2 hours
2 hours

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Aurore BERLAND, ASEI

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2027

Ukończenie studiów (Szacowany)

1 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

23 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

30 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • RC31/26/0048

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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