NCT03686046

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

August 2, 2018

Last Update Submit

May 15, 2019

Conditions

Hearing Loss, Sensorineural

Keywords

Hearing aid

Outcome Measures

Primary Outcomes (1)

  • Response to structured interview

    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?

    Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.

Secondary Outcomes (4)

  • Electro-acoustic performance of the speech-processing platform

    Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.

  • Aided speech perception

    Approximately 2 weeks after last participant completes the exploratory use, estimated to be about 6 months.

  • Pattern of user self-adjustments.

    Approximately 2 weeks after last participant completes the exploratory use

  • Participant-specified issues, comments, and opinions

    Approximately 2 months after last participant completes the exploratory use, estimated to be about 6 months.

Study Arms (1)

Exploratory use

Brief (2 hour) exploratory use of prototype self-adjusted wearable Master Hearing Aid

Other: Exploratory use

Interventions

Exploratory useOTHER

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.

Exploratory use

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with sensorineural hearing loss Residents of San Diego county and North county, California

You may qualify if:

  • \- Sensorineural hearing loss

You may not qualify if:

  • Cognitively challenged
  • Legally blind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University, Audiology Clinic

San Diego, California, 93402, United States

RECRUITING

Related 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.

    PMID: 29049625RESULT

  • 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.

    PMID: 29894379RESULT

  • 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.

    PMID: 29092590RESULT

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

    PMID: 18469711RESULT

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arthur Boothroyd, Ph.D

    San Diego State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Boothroyd, Ph.D.

CONTACT

6195508951aboothroyd@cox.net

Christy Kirsch, Au,D.

CONTACT

6195944176ckirsch@sdsu.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2018

First Posted

September 26, 2018

Study Start

May 10, 2019

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)