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Evaluation of an Open-source Speech-processing Platform (EOSP)

30 de junio de 2026 actualizado por: San Diego State University
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Part 1 Speech perception tests. You will hear words and sentences under a variety of listening conditions and be asked either to either repeat them or to select what you heard from a set of options. You will also answer a few questions about the speech and the background noise. The goal is to determine the ability of the most recent version of the device to deliver good quality speech that is comfortable and understandable over a range of conditions that are representative of everyday listening.

Part 2. Suitability and Acceptability. You will be asked to respond to a short structured interview about the device. If the device has reached a wearable stage, you will wear it outside the laboratory while engaging in discussion with one of the researchers before completing the interview. The goal is to obtain the opinions of persons with hearing loss about the device itself, and about their willingness to wear it as a hearing aid in their everyday life, if they were to be involved in a research study.

Part 3 is a focus-group session with about 10 hearing-aid users, some of whom will have participated in Parts 1 and 2. Topics will deal with hearing aids in general and about the current version of the experimental device. Discussion will be recorded for later transcription and analysis. The goal is to gain the perspective of hearing-aid users about hearing aids, hearing-aid research, and the acceptability of this experimental device for field research.

Tipo de estudio

De observación

Inscripción (Actual)

22

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

    • California
      • San Diego, California, Estados Unidos, 93402
        • San Diego State University, Audiology Clinic

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

30 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Adults with sensorineural hearing loss Residents of San Diego county and North county, California

Descripción

Inclusion Criteria:

- Sensorineural hearing loss

Exclusion Criteria:

  • Cognitively challenged
  • Legally blind

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Exploratory use
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response to structured interview
Periodo de tiempo: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.

A wearable speech-processing platform for hearing-aid research

  1. How long might you be prepared to wear this device as a hearing aid for purposes of research?
  2. How do you rate the appearance and wearability of the device?
  3. How do you rate the performance of the device as a hearing aid?
  4. What changes might increase your willingness to wear this device for research purposes?
  5. What changes might increase your rating of appearance?
  6. What changes might increase your rating of performance?
Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Electro-acoustic performance of the speech-processing platform
Periodo de tiempo: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Real-ear gain versus frequency curves of the speech-processing platform, before and after self-adjustment during the brief trial, will be obtained with the Verifit 2 hearing-aid test system - using standard audiological clinical procedures. (Mackersie, Boothroyd and Lithgow, 2018).
Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Aided speech perception
Periodo de tiempo: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Participants will repeat prerecorded single syllable words presented at varying levels levels from a loudspeaker. Performance will be assessed as the percentage of speech sounds correctly repeated and will be measured while wearing the speech-processing platform as set before and after self-adjustment. (Boothroyd, 2008)
Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Pattern of user self-adjustments.
Periodo de tiempo: Approximately 2 weeks after last participant completes the exploratory use
Changes of gain and spectral slope initiated by participants in response to changing , estimated to be about 6 months.acoustic conditions will be automatically logged by the self-adjustment software. (Boothroyd and Mackersie (2017)
Approximately 2 weeks after last participant completes the exploratory use
Participant-specified issues, comments, and opinions
Periodo de tiempo: Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.
Focus group for all participants
Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Arthur Boothroyd, Ph.D, San Diego State 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)

10 de mayo de 2019

Finalización primaria (Actual)

15 de mayo de 2020

Finalización del estudio (Actual)

15 de mayo de 2020

Fechas de registro del estudio

Enviado por primera vez

2 de agosto de 2018

Primero enviado que cumplió con los criterios de control de calidad

24 de septiembre de 2018

Publicado por primera vez (Actual)

26 de septiembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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