- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03686046
Evaluation of an Open-source Speech-processing Platform (EOSP)
Studieoversikt
Detaljert beskrivelse
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
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Arthur Boothroyd, Ph.D.
- Telefonnummer: 6195508951
- E-post: aboothroyd@cox.net
Studer Kontakt Backup
- Navn: Christy Kirsch, Au,D.
- Telefonnummer: 6195944176
- E-post: ckirsch@sdsu.edu
Studiesteder
-
-
California
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San Diego, California, Forente stater, 93402
- Rekruttering
- San Diego State University, Audiology Clinic
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Ta kontakt med:
- Christine Kirsch, AuD
- Telefonnummer: 619-594-4176
- E-post: ckirsch@sdsu.edu
-
Ta kontakt med:
- Arthur Boothroyd, PhD
- Telefonnummer: 6195508951
- E-post: aboothroyd@sdsu.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Sensorineural hearing loss
Exclusion Criteria:
- Cognitively challenged
- Legally blind
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Response to structured interview
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Electro-acoustic performance of the speech-processing platform
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Arthur Boothroyd, Ph.D, San Diego State University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 58786
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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