Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
8 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
42
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kucukcekmece
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Istanbul, Kucukcekmece, Turquía (Türkiye), 34295
- Istanbul Aydın University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
Otros nombres:
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Eco-HINT
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Speech, Spatial Perception and Hearing Quality Scale
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Audible Contrast Threshold (ACT)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Sule Cekic, associate professor, Ankara Yildirim Beyazıt University
- Director de estudio: Umıt Can Cetinkaya, assistant professor, Istanbul Aydın University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de febrero de 2025
Finalización primaria (Actual)
2 de mayo de 2025
Finalización del estudio (Actual)
1 de junio de 2025
Fechas de registro del estudio
Enviado por primera vez
31 de marzo de 2025
Primero enviado que cumplió con los criterios de control de calidad
8 de agosto de 2026
Publicado por primera vez (Actual)
11 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de agosto de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Comportamiento
- Comportamiento espacial
- Orientación, Espacial
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Salud pública
- Medio ambiente y salud pública
- Fenómeno fisiológico
- Fenómeno físico
- Ambiente
- Fenómenos ecológicos y ambientales
- Fenómeno biológico
- Radiación
- Radiación, nonionizante
- Sistema nervioso Fenómenos fisiológicos
- Sonido
- Sensación
- Contaminación ambiental
- Fenómenos fisiológicos vestibulococlear
- Ruido
- Audiencia
Otros números de identificación del estudio
- 61351342/020-385
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .