- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03686046
Evaluation of an Open-source Speech-processing Platform (EOSP)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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California
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San Diego, California, États-Unis, 93402
- Recrutement
- San Diego State University, Audiology Clinic
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Contact:
- Christine Kirsch, AuD
- Numéro de téléphone: 619-594-4176
- E-mail: ckirsch@sdsu.edu
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Contact:
- Arthur Boothroyd, PhD
- Numéro de téléphone: 6195508951
- E-mail: aboothroyd@sdsu.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Sensorineural hearing loss
Exclusion Criteria:
- Cognitively challenged
- Legally blind
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Exploratory use
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Response to structured interview
Délai: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
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A wearable speech-processing platform for hearing-aid research
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Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Electro-acoustic performance of the speech-processing platform
Délai: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
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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).
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Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
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Aided speech perception
Délai: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
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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)
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Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
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Pattern of user self-adjustments.
Délai: Approximately 2 weeks after last participant completes the exploratory use
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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)
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Approximately 2 weeks after last participant completes the exploratory use
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Participant-specified issues, comments, and opinions
Délai: Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.
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Focus group for all participants
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Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Arthur Boothroyd, Ph.D, San Diego State University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 58786
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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