- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07675941
Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age (SI 360)
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
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Marie-Noëlle CALMELS, Dr
- Número de telefone: +33 5-61-77-95-77
- E-mail: calmels.mn@chu-toulouse.fr
Estude backup de contato
- Nome: Aurore BERLAND
- E-mail: aurore.berland@asei.asso.fr
Locais de estudo
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-
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Ramonville-Saint-Agne, França, 31522
- ASEI, Unité Ressources Audition
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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
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
|
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Difference between scores obtained with the 360 Immersion System and scores from the literature
Prazo: 2 hours
|
2 hours
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Aurore BERLAND, ASEI
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- RC31/26/0048
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