Back to resultsNew Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients. (PRESENCE-MU)
Primary Purpose
Hearing Loss
Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Investigational Pre-Processing Algorithm
Cochlear Limited standard-of-care pre-processing algorithms
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria: User of an approved Nucleus cochlear implant. User of the ACE (Advanced Combination Encoder) sound processing strategy. Aged 18 years or older (no upper age limit). Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator. Willing and able to provide written informed consent. ≥3 months post cochlear implant activation Exclusion Criteria: Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations. Investigator site personnel directly affiliated with this study and/or the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Sites / Locations
- Cochlear Melbourne
- HEARnet Clinical Studies
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm
Arm Description
Outcomes
Primary Outcome Measures
Australian Sentence Test in Noise (AuSTIN)
To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores.
Scoring: AuSTIN is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence.
Range: -30dB to +30dB. Lower scores reflect a better outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06100393
Brief Title
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
Acronym
PRESENCE-MU
Official Title
A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients: a Master Umbrella Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
Detailed Description
This is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. The Master Umbrella design will enable the execution of a series of sub-investigations in the same user population, with the goal to evaluate a range of speech enhancement pre-processing algorithms in separate sub-investigations. The primary objectives for each sub-investigation will be consistent with the master umbrella investigation, with secondary and exploratory objectives selected based on the algorithm to be investigated. Secondary and exploratory objectives will be described in the sub-investigation documentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Order of IMD and comparator is blinded.
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Investigational Pre-Processing Algorithm
Intervention Description
The algorithms act upon the digital audio signal received by the microphones and other sensors to enhance speech and attenuate noise prior to encoding the signal for delivery to a cochlear implant via the specified system.
Intervention Type
Device
Intervention Name(s)
Cochlear Limited standard-of-care pre-processing algorithms
Intervention Description
Automatic Gain Control, SNR-NR, Forward Focus
Primary Outcome Measure Information:
Title
Australian Sentence Test in Noise (AuSTIN)
Description
To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores.
Scoring: AuSTIN is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence.
Range: -30dB to +30dB. Lower scores reflect a better outcome.
Time Frame
1 day - Immediately post-screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
User of an approved Nucleus cochlear implant.
User of the ACE (Advanced Combination Encoder) sound processing strategy.
Aged 18 years or older (no upper age limit).
Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.*
Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
Willing and able to provide written informed consent.
≥3 months post cochlear implant activation
Exclusion Criteria:
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
Investigator site personnel directly affiliated with this study and/or the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.
Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Fullerton
Phone
+61 477958930
Email
afullerton@cochlear.com
Facility Information:
Facility Name
Cochlear Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Fullerton, PhD
Phone
+61 477958930
Email
afullerton@cochlear.com
Facility Name
HEARnet Clinical Studies
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karyn Galvin, PhD
Phone
+61 407052505
Email
kgalvin@unimelb.edu.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
We'll reach out to this number within 24 hrs