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

23 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

150

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

Children aged 7 to 15 with normal hearing

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
percentage of correct word identification
Prazo: 2 hours
2 hours

Medidas de resultados secundários

Medida de resultado
Prazo
average of auditory data
Prazo: 2 hours
2 hours
difference between a natural sound environment vs. a SpeechInNoise environment
Prazo: 2 hours
2 hours
Difference between scores obtained with the 360 Immersion System and scores from the literature
Prazo: 2 hours
2 hours

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Aurore BERLAND, ASEI

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

1 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2026

Primeira postagem (Real)

30 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • RC31/26/0048

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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