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- Klinische proef NCT03686046
Evaluation of an Open-source Speech-processing Platform (EOSP)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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California
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San Diego, California, Verenigde Staten, 93402
- San Diego State University, Audiology Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Sensorineural hearing loss
Exclusion Criteria:
- Cognitively challenged
- Legally blind
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Response to structured interview
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Electro-acoustic performance of the speech-processing platform
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Arthur Boothroyd, Ph.D, San Diego State University
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 58786
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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