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

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ClinicalTrials.gov Identifier: NCT03686046
Recruitment Status : Unknown
Verified May 2019 by Arthur Boothroyd, San Diego State University.
Recruitment status was:  Recruiting
First Posted : September 26, 2018
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Arthur Boothroyd, San Diego State University

Study Description
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Brief Summary:
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research

Condition or disease Intervention/treatment
Hearing Loss, Sensorineural Other: Exploratory use

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of an Open-source Speech-processing Platform
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Groups and Cohorts
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Group/Cohort Intervention/treatment
Exploratory use
Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid
 Other: Exploratory use
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.


Outcome Measures
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Primary Outcome Measures :
  1. Response to structured interview [ Time Frame: 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?


Secondary Outcome Measures :
  1. Electro-acoustic performance of the speech-processing platform [ Time Frame: 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).

  2. Aided speech perception [ Time Frame: 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)

  3. Pattern of user self-adjustments. [ Time Frame: 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)

  4. Participant-specified issues, comments, and opinions [ Time Frame: Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months. ]
    Focus group for all participants


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with sensorineural hearing loss Residents of San Diego county and North county, California
Criteria

Inclusion Criteria:

- Sensorineural hearing loss

Exclusion Criteria:

  • Cognitively challenged
  • Legally blind
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686046


Contacts
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Contact: Arthur Boothroyd, Ph.D. 6195508951 aboothroyd@cox.net
Contact: Christy Kirsch, Au,D. 6195944176 ckirsch@sdsu.edu

Locations
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United States, California
San Diego State University, Audiology Clinic Recruiting
San Diego, California, United States, 93402
Contact: Christine Kirsch, AuD    619-594-4176    ckirsch@sdsu.edu   
Contact: Arthur Boothroyd, PhD    6195508951    aboothroyd@sdsu.edu   
Sponsors and Collaborators
San Diego State University
University of California, San Diego
Investigators
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Principal Investigator: Arthur Boothroyd, Ph.D San Diego State University
More Information
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Publications of Results:

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Responsible Party: Arthur Boothroyd, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT03686046    
Other Study ID Numbers: 58786
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arthur Boothroyd, San Diego State University:
Hearing aid
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases