The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
17 de julho de 2026 atualizado por: University Hospital, Antwerp
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients.
Speech perception in noise will be assessed using different spatial configurations of speech and noise.
Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ).
Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
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.
Locais de estudo
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Antwerp, Bélgica, 2650
- Recrutamento
- Antwerp University Hopsital
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Contato:
- Emilie Heuninck
- Número de telefone: 00324368422
- E-mail: emilie.heuninck@uza.be
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age ≥ 18 years
- Post-lingual onset of unilateral severe-to-profound sensorineural hearing loss
- Contralateral hearing < 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)
- Post-operative Computed Tomography (CT) scan of the CI elec-trode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex20, Flex24, Flex28, FlexSoft, Flex34 or Standard electrode
- Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side
- Newly implanted CI users
- The most apical active electrode contact has to be inserted at least 540°
- Minimum of 10 active channels can be activated
- Fluent in the language of the test centre
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
Exclusion Criteria:
- Lack of compliance with any inclusion criteria
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Anatomy-based fitting
Anatomy-based programming of the speech processor of the cochlear implant
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Anatomy-based programming of the speech processor of the cochlear implant
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Comparador Ativo: Default fitting
Default programming of the speech processor of the cochlear implant according to standard clinical practice
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Default programming of the speech processor of the cochlear implant according to standard clinical practice
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Speech perception in noise
Prazo: 3 months post-activation of the audioprocessor
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Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
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3 months post-activation of the audioprocessor
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Speech perception in noise
Prazo: 6 months post-activation of the audioprocessor
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Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
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6 months post-activation of the audioprocessor
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Speech perception in noise
Prazo: 12 months post-activation of the audioprocessor
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Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
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12 months post-activation of the audioprocessor
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pitch ranking
Prazo: 3 months post-activation
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Frequency difference in semitones between CI and NH
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3 months post-activation
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Pitch ranking
Prazo: 6 months post-activation
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Frequency difference in semitones between CI and NH
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6 months post-activation
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Pitch ranking
Prazo: 12 months post-activation
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Frequency difference in semitones between CI and NH
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12 months post-activation
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Perception of timbre
Prazo: 3 months post-activation
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Score on Visual Analog Scale (VAS).
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
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3 months post-activation
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Perception of timbre
Prazo: 6 months post-activation
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Score on Visual Analog Scale (VAS).
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
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6 months post-activation
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Perception of timbre
Prazo: 12 months post-activation
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Score on Visual Analog Scale (VAS).
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
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12 months post-activation
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Localization
Prazo: 3 months post-activation
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Root mean square localization error (RMSE) in degrees
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3 months post-activation
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Localization
Prazo: 6 months post-activation
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Root mean square localization error (RMSE) in degrees
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6 months post-activation
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Localization
Prazo: 12 months post-activation
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Root mean square localization error (RMSE) in degrees
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12 months post-activation
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Melodic interval perception
Prazo: 3 months post-activation
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Psychometric function of melodic intervals
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3 months post-activation
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Melodic interval perception
Prazo: 6 months post-activation
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Psychometric function of melodic intervals
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6 months post-activation
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Melodic interval perception
Prazo: 12 months post-activation
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Psychometric function of melodic intervals
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12 months post-activation
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Sound quality
Prazo: 3 months post-activation
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Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
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3 months post-activation
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Sound quality
Prazo: 6 months post-activation
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Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
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6 months post-activation
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Sound quality
Prazo: 12 months post-activation
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Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
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12 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Prazo: 3 months post-activation
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Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
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3 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Prazo: 6 months post-activation
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Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
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6 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Prazo: 12 months post-activation
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Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
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12 months post-activation
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HISQUI19 questionnaire
Prazo: 3 months post-activation
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Total score and classification of self-perceived auditory benefit.
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%).
To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added.
Uncompleted items and the response option "not applicable" correspond to 0 in this calculation.
A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
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3 months post-activation
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HISQUI19 questionnaire
Prazo: 6 months post-activation
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Total score and classification of self-perceived auditory benefit.
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%).
To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added.
Uncompleted items and the response option "not applicable" correspond to 0 in this calculation.
A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
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6 months post-activation
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HISQUI19 questionnaire
Prazo: 12 months post-activation
|
Total score and classification of self-perceived auditory benefit.
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%).
To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added.
Uncompleted items and the response option "not applicable" correspond to 0 in this calculation.
A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
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12 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Prazo: 3 months post-activation
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Total score and score in the speech, spatial and quality domain.
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items.
For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
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3 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Prazo: 6 months post-activation
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Total score and score in the speech, spatial and quality domain.
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items.
For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
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6 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Prazo: 12 months post-activation
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Total score and score in the speech, spatial and quality domain.
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items.
For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
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12 months post-activation
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Griet Mertens, Prof., University Hospital, Antwerp
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 (Real)
26 de junho de 2025
Conclusão Primária (Estimado)
1 de dezembro de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
9 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de julho de 2026
Primeira postagem (Real)
14 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-7636
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