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Cochlear Implant Low Power Strategy

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
MP3000 sound coding strategy or ACE strategy with lower stimulation
Sponsored by
The Hearing Cooperative Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring cochlear implants, power consumption,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult (>18 years) cochlear implant recipients
  2. Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
  3. User of commercially available Freedom, CP810 or CP900 series sound processor
  4. User of the ACE strategy or MP3000 strategy
  5. At least 3 months experience with the cochlear implant
  6. Native speaker in the language used to assess speech perception performance
  7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

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

Sites / Locations

  • The HEARing CRC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MP3000-ACE strategy

Arm Description

MP3000 sound coding strategy or ACE strategy with lower stimulation rate

Outcomes

Primary Outcome Measures

Word recognition scores in quiet
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
Sentence recognition scores in quiet
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy

Secondary Outcome Measures

Fundamental frequency (F0) discrimination
F0 discrimination for MP3000 strategy compared to the ACE baseline
Speech intelligibility and helpfulness subjective ratings
For MP3000 strategy compared to the default ACE baseline
Sentence in noise scores
Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.

Full Information

First Posted
August 21, 2016
Last Updated
July 2, 2021
Sponsor
The Hearing Cooperative Research Centre
Collaborators
Royal Victoria Eye and Ear Hospital, Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT02879539
Brief Title
Cochlear Implant Low Power Strategy
Official Title
Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
January 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearing Cooperative Research Centre
Collaborators
Royal Victoria Eye and Ear Hospital, Cochlear

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
cochlear implants, power consumption,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP3000-ACE strategy
Arm Type
Experimental
Arm Description
MP3000 sound coding strategy or ACE strategy with lower stimulation rate
Intervention Type
Device
Intervention Name(s)
MP3000 sound coding strategy or ACE strategy with lower stimulation
Primary Outcome Measure Information:
Title
Word recognition scores in quiet
Description
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
Time Frame
Testing over 18 weeks
Title
Sentence recognition scores in quiet
Description
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy
Time Frame
Testing over 18 weeks
Secondary Outcome Measure Information:
Title
Fundamental frequency (F0) discrimination
Description
F0 discrimination for MP3000 strategy compared to the ACE baseline
Time Frame
Testing over 18 weeks
Title
Speech intelligibility and helpfulness subjective ratings
Description
For MP3000 strategy compared to the default ACE baseline
Time Frame
Testing over 18 weeks
Title
Sentence in noise scores
Description
Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.
Time Frame
Testing over 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 or MP3000 strategy At least 3 months experience with the cochlear implant Native speaker in the language used to assess speech perception performance Willingness to participate in and to comply with all requirements of the protocol Exclusion Criteria: 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
Facility Information:
Facility Name
The HEARing CRC
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Cochlear Implant Low Power Strategy

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