Clinical trial NCT03686046: Evaluation of an Open-source Speech-processing Platform
Official title: Evaluation of an Open-source Speech-processing Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss, Sensorineural
Keywords: Hearing aid
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2018-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with sensorineural hearing loss Residents of San Diego county and North county, California

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

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.

Eligibility criteria: Inclusion Criteria:

- Sensorineural hearing loss

Exclusion Criteria:

* Cognitively challenged
* Legally blind

Primary outcomes:
measure: Response to structured interview
timeFrame: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
Secondary outcomes:
measure: Electro-acoustic performance of the speech-processing platform
timeFrame: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
measure: Aided speech perception
timeFrame: Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.
measure: Pattern of user self-adjustments.
timeFrame: Approximately 2 weeks after last participant completes the exploratory use
measure: Participant-specified issues, comments, and opinions
timeFrame: Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University, Audiology Clinic
state: California
Study officials:
affiliation: San Diego State University
name: Arthur Boothroyd, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: Boothroyd A. The performance/intensity function: an underused resource. Ear Hear. 2008 Aug;29(4):479-91. doi: 10.1097/AUD.0b013e318174f067.