NCT03661970

Brief Summary

The primary purpose of the research is to study how synthesized speech and non-speech percepts (sounds) are recognized in subjects with cochlear implants (CI) who are not getting functional speech recognition using existing speech to CI algorithms. By identifying a partial set of phonemes (units of speech) from this CI feedback, a new language could be developed.

Trial Health

57
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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

4.9 years

First QC Date

September 5, 2018

Last Update Submit

February 16, 2024

Conditions

DeafnessSound PerceptionQuality of Sound

Outcome Measures

Primary Outcomes (1)

  • Recognition of synthesized speech and non-speech percepts (sounds)

    Self reported detection and differentiation of sounds generated by the Cognate Speech Synthesizer.

    60 minutes

Study Arms (3)

Normal subjects hearing group

After education on the use of the Cognate Speech Synthesizer the participant will be asked to demonstrate specific tasks on the Cognate Speech Synthesizer testing their search patterns of interests, use-ability, and acoustic vamp values on the Cognate Speech Synthesizer.

Other: Cognate Speech Synthesizer sound percepts

Cochlear implant subjects with good speech recognition

After education on the use of the Cognate Speech Synthesizer the participant will be asked to demonstrate specific tasks on the Cognate Speech Synthesizer testing their search patterns of interests, use-ability, and acoustic vamp values on the Cognate Speech Synthesizer.

Other: Cognate Speech Synthesizer sound percepts

Cochlear implant subjects without good speech recognition

After education on the use of the Cognate Speech Synthesizer the participant will be asked to demonstrate specific tasks on the Cognate Speech Synthesizer testing their search patterns of interests, use-ability, and acoustic vamp values on the Cognate Speech Synthesizer.

Other: Cognate Speech Synthesizer sound percepts

Interventions

Cognate Speech Synthesizer sound perceptsOTHER

The cognate speech synthesizer will generate an acoustic output, as well as a visual display of the acoustic signals. The outputs on the monitor and the synthesizer will be recorded.

Cochlear implant subjects with good speech recognitionCochlear implant subjects without good speech recognitionNormal subjects hearing group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Adults without Cochlear Implant Healthy Adults with Cochlear Implant

You may qualify if:

  • Adults who are at least 18 years of age
  • Must have normal visual acuity as evidenced by the ability to read and write notes to and from study staff when necessary
  • Must be fluent reading and writing English
  • No confounding or concomitant medical issues except for deafness
  • Must be able to understand and perform assigned tasks
  • Must be computer literate
  • Normal hearing OR adult with compatible cochlear implant (Cochlear Nucleus 24 series cochlear implants)

You may not qualify if:

  • Incompatible Cochlear Implant device
  • Less than 18 years of age
  • Not able to speak, read, or write English
  • Adult with less than six month's experience with their CI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cadwell Industries Inc

Kennewick, Washington, 99336, United States

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

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

Study Officials

  • John Cadwell, MD

    Affiliate Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

June 10, 2018

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)