Evaluation of an Open-source Speech-processing Platform

Hearing Loss, Sensorineural Clinical Trial

— EOSP  

Official title:

Evaluation of an Open-source Speech-processing Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03686046
• Other study ID #: 58786
• Status: Recruiting
• Start date: May 10, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2019
• Source: San Diego State University
• Contact: Arthur Boothroyd, Ph.D.
• Phone: 6195508951
• Email: aboothroyd[@]cox.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Sensorineural hearing loss

Exclusion Criteria:

• Cognitively challenged

• Legally blind

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

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.

Locations

Country	Name	City	State
United States	San Diego State University, Audiology Clinic	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Boothroyd A. The performance/intensity function: an underused resource. Ear Hear. 2008 Aug;29(4):479-91. doi: 10.1097/AUD.0b013e318174f067. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to structured interview	A wearable speech-processing platform for hearing-aid research; How long might you be prepared to wear this device as a hearing aid for purposes of research?; How do you rate the appearance and wearability of the device?; How do you rate the performance of the device as a hearing aid?; What changes might increase your willingness to wear this device for research purposes?; What changes might increase your rating of appearance?; What changes might increase your rating of performance?	Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Secondary	Electro-acoustic performance of the speech-processing platform	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.
Secondary	Aided speech perception	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.
Secondary	Pattern of user self-adjustments.	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
Secondary	Participant-specified issues, comments, and opinions	Focus group for all participants	Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.