- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03686046
Evaluation of an Open-source Speech-processing Platform (EOSP)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
California
-
San Diego, California, Estados Unidos, 93402
- San Diego State University, Audiology Clinic
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Sensorineural hearing loss
Exclusion Criteria:
- Cognitively challenged
- Legally blind
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Response to structured interview
Prazo: 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
|
Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Electro-acoustic performance of the speech-processing platform
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Arthur Boothroyd, Ph.D, San Diego State University
Publicações e links úteis
Publicações Gerais
- Boothroyd A, Mackersie C. A "Goldilocks" Approach to Hearing-Aid Self-Fitting: User Interactions. Am J Audiol. 2017 Oct 12;26(3S):430-435. doi: 10.1044/2017_AJA-16-0125.
- Mackersie C, Boothroyd A, Lithgow A. A "Goldilocks" Approach to Hearing Aid Self-Fitting: Ear-Canal Output and Speech Intelligibility Index. Ear Hear. 2019 Jan/Feb;40(1):107-115. doi: 10.1097/AUD.0000000000000617.
- Lee CH, Kates JM, Rao BD, Garudadri H. Speech quality and stable gain trade-offs in adaptive feedback cancellation for hearing aids. J Acoust Soc Am. 2017 Oct;142(4):EL388. doi: 10.1121/1.5007278.
- Boothroyd A. The performance/intensity function: an underused resource. Ear Hear. 2008 Aug;29(4):479-91. doi: 10.1097/AUD.0b013e318174f067.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 58786
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .