Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
8 de agosto de 2026 atualizado por: Melek Başak ÖZKAN, Istanbul Aydın University
Hearing speech in the presence of background noise is a significant challenge for those with hearing loss.
Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users.
Our study aims to evaluate the effects of adaptation to hearing test in noise on speech perception, spatial perception and satisfaction in bilateral hearing aid users.
The development process of speech understanding in noise in individuals with hearing loss over the age of 50 will be monitored with ACT and ecological-HINT tests.
Spatial perception will be assessed with the Speech, Spatial Perception and Hearing Quality (SHRQ) Scale, which is a scale that evaluates the current hearing quality in adults.
The hearing aid satisfaction process of the participants will be assessed with the APHAB survey.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Hypotheses:
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H0: Using ACT in the fitting does not increase speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting increases speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting has no effect on improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting has an effect on improving spatial perception performance in hearing aid users.
H0: Using ACT in fitting has no effect on increasing hearing aid satisfaction in hearing aid users.
H1: Using ACT in fitting has an effect on increasing hearing aid satisfaction in hearing aid users.
Tipo de estudo
Intervencional
Inscrição (Real)
42
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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Kucukcekmece
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Istanbul, Kucukcekmece, Turquia (Türkiye), 34295
- Istanbul Aydın University
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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:
- Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965)
- SDS score between 70-100%
- Being a bilateral hearing aid user
- Being a user of Oticon, Philips, Bernafon hearing aids
- Being between 18-50 years of age
- Signing an informed consent form
Exclusion Criteria:
- Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs
- Complaining with tinnitus
- Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test
- Not signing an informed consent form
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: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Experimental Group
The ACT method will be applied to the study group in fitting, and the results will be recorded by applying the KUİK scale and APHAB survey after fitting.
They will be called for control in the 1st week and 1st month, and fitting and scale evaluations will be made and the results will be recorded.
Participants' discrimination in noise with ACT and Turkish Matrix Test, evaluation of spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be evaluated in the initial and 1st month time periods.
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The ACT diagnostic test is a suprathreshold, non-language-specific test that measures an individual's hearing ability in real-world noisy environments to determine the level of assistance needed in noise.
The test uses the audiogram shape and levels to ensure the correct stimulus intensity is applied.
The ACT test then uses the patient's audiogram to present a suprathreshold stimulus (a siren-like sound) to objectively map their hearing ability in noisy environments.
In other words, the audiogram measures quantity, i.e. hearing ability, while the ACT measures the quality of hearing.
This makes the ACT a robust assessment that reflects an individual's real-world hearing abilities.
Outros nomes:
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Comparador Ativo: Control Group
The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting.
Fitting and scale assessments will be made at week 1 and month 1, and the results will be recorded.
Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception assessment with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1.
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The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting.
They will be called for a check-up at week 1 and month 1, and fitting and scale assessments will be made, and the results will be recorded.
Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1.
All findings will be compared and statistically analyzed.
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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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Eco-HINT
Prazo: 1 week and 1 month after hearing aid fitting
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Speech-in-noise performance was assessed using the ecologically valid Hearing in Noise Test (eco-HINT).
Speech reception thresholds were measured under aided and unaided listening conditions.
Lower scores indicate better speech-in-noise performance.
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1 week and 1 month after hearing aid fitting
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Speech, Spatial Perception and Hearing Quality Scale
Prazo: 1 week and 1 month after hearing aid fitting
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The individual who is applied the scale evaluates himself/herself and answers each question between 0 and 10 points.
All scores are added up and divided by 49 to obtain the "General KUİK score".
The scores under the heading of Speech Perception are added up and divided by 14 to obtain the KA score, the scores under the heading of Spatial Perception are added up and divided by 17 to obtain the UA score, and the scores under the heading of Hearing Quality are added up and divided by 18 to obtain the İK score.
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1 week and 1 month after hearing aid fitting
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APHAB survey
Prazo: 1 week and 1 month after hearing aid fitting
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APHAB is a survey that allows us to numerically measure the benefits and satisfaction of individuals with hearing loss from their hearing aids in daily hearing situations.
Survey questions are answered according to two different listening situations: "without my hearing aid" and "with my hearing aid".
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1 week and 1 month after hearing aid fitting
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Audible Contrast Threshold (ACT)
Prazo: Time Frame: 1 week and 1 month after hearing aid fitting
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The ACT is a suprathreshold, non-language-specific test that measures an individual's ability to hear in real-world noisy environments to determine the level of assistance needed in noise.
ACT values are determined by level of intensity.
A normal ACT value is between -4 and +4 dB nCL. 4 to 7 dB nCL indicates mild loss, 7 to 10 dB nCL indicates moderate loss, and 10 to 16 dB nCL indicates profound loss.
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Time Frame: 1 week and 1 month after hearing aid fitting
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Sule Cekic, associate professor, Ankara Yildirim Beyazıt University
- Diretor de estudo: Umıt Can Cetinkaya, assistant professor, Istanbul Aydın University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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)
13 de fevereiro de 2025
Conclusão Primária (Real)
2 de maio de 2025
Conclusão do estudo (Real)
1 de junho de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
31 de março de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de agosto de 2026
Primeira postagem (Real)
11 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de agosto de 2026
Última verificação
1 de março de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Comportamento
- Comportamento espacial
- Orientação, Espacial
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Saúde pública
- Meio ambiente e saúde pública
- Fenômenos fisiológicos
- Fenômenos físicos
- Ambiente
- Fenômenos ecológicos e ambientais
- Fenômenos biológicos
- Radiação
- Radiação, não ionizante
- Fenômenos fisiológicos do sistema nervoso
- Som
- Sensação
- Poluição ambiental
- Fenômenos fisiológicos vestibulococleares
- Barulho
- Audição
Outros números de identificação do estudo
- 61351342/020-385
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
To ensure the privacy and confidentiality of participants, individual participant data (IPD) will not be shared.
Since the study involves hearing aid users, it is extremely important to protect the integrity of their personal data.
Furthermore, the guidelines of the ethics committee and institutional policies require strict data protection to prevent possible misuse.
Therefore, IPD will remain confidential and will not be made public.
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
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