NCT02746172

Brief Summary

The aim of this research is to investigate the potential use of specific metrics in assessing the quality and optimising an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to determining best methods for streamlined high quality fitting, providing the potential for feedback to the individual and clinic, as well as automated adjustments for optimisation. Ultimately the objective is to increase clinical capacity for managing both the installed base and new candidates for cochlear implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 16, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

April 13, 2016

Last Update Submit

July 2, 2021

Conditions

Hearing Loss

Keywords

cochlear implantsMappingin-situ audiometry

Outcome Measures

Primary Outcomes (4)

  • Sensitivity of percentage words/ phonemes correct, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.

    Testing over 12 weeks

  • Sensitivity of speech reception threshold for numbers and sentences in noise, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.

    Testing over 12 weeks

  • Sensitivity of aided hearing thresholds, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.

    Testing over 12 weeks

  • Sensitivity of loudness ratings for narrow band noise presented at different frequencies and levels, in detecting MAPs with inaccurate T and C levels in cochlear implant MAPs.

    Testing over 12 weeks

Secondary Outcomes (1)

  • Test-retest reliability of in-situ aided audiometry

    Testing over 6 weeks

Study Arms (2)

Cochlear Implant Recipients

EXPERIMENTAL

cochlear implant recipients

Device: Cochlear implant with in-situ audiometry

Normal Hearing Volunteers

NO INTERVENTION

Normal hearing volunteers

Interventions

Cochlear implant with in-situ audiometryDEVICE
Cochlear Implant Recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 years) cochlear implant recipients
  • Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
  • User of commercially available Freedom, CP810 or CP900 series sound processor
  • User of the ACE strategy
  • At least 3 months experience with the cochlear implant
  • Fluent speaker in the language used to assess speech perception performance
  • Willingness to participate in and to comply with all requirements of the protocol

You may not qualify if:

  • Additional handicaps that would prevent participation in evaluations
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The HEARing CRC

Melbourne, Victoria, 3010, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 21, 2016

Study Start

November 16, 2015

Primary Completion

October 17, 2017

Study Completion

October 17, 2017

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)