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Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation (INSPIRE)

Primary Purpose

Hearing Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cochlear™ Remote care
Standard of care
Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss focused on measuring Cochlear Implant aftercare, Remote clinical management

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 years or older (no upper age limit)
  • Post-lingually deafened
  • Unilaterally implanted with the CI600 Series (CI612, CI622, CI632), CI500 Series (CI512, CI522, CI532) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422)
  • Currently using a Nucleus 7 (CP1000) or Kanso 2 (CP1050) Sound Processor (or latest compatible Sound Processor)
  • 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
  • Owner of a compatible Smart Phone
  • Fluent in the languages used for the study, as determined by the investigator
  • Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:

    • Non-monopolar MAPs (bipolar, common ground, variable mode)
    • Dynamic range of <10 Comfortable Level (CL)
    • Hybrid mode enabled
    • Pulse widths >100 µs
    • 10 or more electrodes turned off
  • Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances
  • Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation
  • Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
  • Abnormal cochlea anatomy and/or facial nerve stimulation
  • Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
  • Cochlear employees or employees of Contract Research Organisations 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

  • UZ Gent
  • UZ Leuven
  • University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
  • Azienda Ospedale Università di Padova
  • Academisch Ziekenhuis Maastricht
  • Radboud University Medical Centre Nijmegen
  • Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
  • Auditory Implant Centre, Glan Clwyd Hospital
  • St Thomas' Hospital
  • St George's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cochlear™ Remote care

Standard of care

Arm Description

Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.

Routine In-clinic care

Outcomes

Primary Outcome Measures

Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation
Measuring change of speech, spatial and hearing experiences (12 items). Each item is scored on a scale of 0 to 10 where 0 corresponds to "complete inability or complete absence of a quality" and 10 to "complete ability or complete presence of an ability". The score of a participant is determined as the mean of the 12 items. Higher scores indicate less hearing disability

Secondary Outcome Measures

Mean change in speech recognition score for an open-set word recognition measure in quiet between 3 months post-activation (baseline) and 12 months post-activation
The test is done using phonetically balanced words and scores are recorded as % correct words. Higher scores indicate a better outcome.
Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation
The test is done using validated lists of phonetically balanced sentences. The noise is kept constant at 65 decibel (dB) Sound Pressure Level (SPL), and the speech is adapted stepwise to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. Lower scores indicate a better outcome.
Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.
Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation
Measuring satisfaction of participants with the healthcare service (8 questions). Each item is scored using a 4-point Likert scale with 1 always indicating a negative response and 4 a positive response. A total higher score indicates higher satisfaction
Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation
Evaluating the knowledge, skills, beliefs, and behaviours that participants have for self-management of their long-term health condition (13 items). Each item is scored on a 4-point likert scale from 1 (strongly disagree) to 4 (strongly agree). The overall score is calculated and normalized to a 100-point scale. Higher scores indicate greater levels of activation.

Full Information

First Posted
September 6, 2022
Last Updated
June 9, 2023
Sponsor
Cochlear
Collaborators
QbD Clinical, Avania
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1. Study Identification

Unique Protocol Identification Number
NCT05552118
Brief Title
Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation
Acronym
INSPIRE
Official Title
A Post-Market, Prospective, Multi-Centre, Open-Label, Comparative, Interventional Study of Adult Cochlear Implant Speech Performance and Clinic Efficiency With Remote Care (Remote Check & Remote Assist) Compared With Standard of Care in the First 12 Months Post-initial Activation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
QbD Clinical, Avania

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 aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Cochlear Implant aftercare, Remote clinical management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cochlear™ Remote care
Arm Type
Experimental
Arm Description
Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Routine In-clinic care
Intervention Type
Procedure
Intervention Name(s)
Cochlear™ Remote care
Intervention Description
Cochlear™ Remote Check is a virtual assessment tool which helps the clinician to monitor the participant hearing progress remotely. It allows the participant to complete a series of hearing tests using the Cochlear™ Nucleus® Smart App then electronically send the results to the clinician for review. Cochlear™ Remote Assist enables a video call appointment through the Cochlear™ Custom Sound® Pro software and the Nucleus® Smart App. When remote check requires further follow-up, it allows the clinician to make programming adjustments and sound processor settings without a clinic visit.
Intervention Type
Procedure
Intervention Name(s)
Standard of care
Intervention Description
Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro
Intervention Type
Device
Intervention Name(s)
Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)
Intervention Description
CI600 Series (CI612, CI622, CI632), CI500 Series (CI512, CI522, CI532), Freedom Series (CI24RE(CA), CI24RE(ST), CI422). Nucleus 7 (CP1000) or Kanso 2 (CP1050)
Primary Outcome Measure Information:
Title
Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation
Description
Measuring change of speech, spatial and hearing experiences (12 items). Each item is scored on a scale of 0 to 10 where 0 corresponds to "complete inability or complete absence of a quality" and 10 to "complete ability or complete presence of an ability". The score of a participant is determined as the mean of the 12 items. Higher scores indicate less hearing disability
Time Frame
3 months post-activation (baseline) and 12 months post-activation
Secondary Outcome Measure Information:
Title
Mean change in speech recognition score for an open-set word recognition measure in quiet between 3 months post-activation (baseline) and 12 months post-activation
Description
The test is done using phonetically balanced words and scores are recorded as % correct words. Higher scores indicate a better outcome.
Time Frame
3 months post-activation (baseline) and 12 months post-activation
Title
Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation
Description
The test is done using validated lists of phonetically balanced sentences. The noise is kept constant at 65 decibel (dB) Sound Pressure Level (SPL), and the speech is adapted stepwise to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. Lower scores indicate a better outcome.
Time Frame
3 months post-activation (baseline) and 12 months post-activation
Title
Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire.
Time Frame
3 months post-activation (baseline) and 12 months post-activation
Title
Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire
Time Frame
3 months post-activation (baseline) and 12 months post-activation
Title
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation
Description
Measuring satisfaction of participants with the healthcare service (8 questions). Each item is scored using a 4-point Likert scale with 1 always indicating a negative response and 4 a positive response. A total higher score indicates higher satisfaction
Time Frame
12 months post-activation
Title
Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation
Description
Evaluating the knowledge, skills, beliefs, and behaviours that participants have for self-management of their long-term health condition (13 items). Each item is scored on a 4-point likert scale from 1 (strongly disagree) to 4 (strongly agree). The overall score is calculated and normalized to a 100-point scale. Higher scores indicate greater levels of activation.
Time Frame
12 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older (no upper age limit) Post-lingually deafened Unilaterally implanted with the CI600 Series (CI612, CI622, CI632), CI500 Series (CI512, CI522, CI532) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422) Currently using a Nucleus 7 (CP1000) or Kanso 2 (CP1050) Sound Processor (or latest compatible Sound Processor) 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements Owner of a compatible Smart Phone Fluent in the languages used for the study, as determined by the investigator Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm Willing and able to provide written informed consent Exclusion Criteria: Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming: Non-monopolar MAPs (bipolar, common ground, variable mode) Dynamic range of <10 Comfortable Level (CL) Hybrid mode enabled Pulse widths >100 µs 10 or more electrodes turned off Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ) Abnormal cochlea anatomy and/or facial nerve stimulation Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling Cochlear employees or employees of Contract Research Organisations 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
PRS Specialist, Clinical Affairs
Phone
+61 2 9428 6555
Email
cltd-prs-admin@cochlear.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherith Campbell-Bell
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
City
Bari
ZIP/Postal Code
70120
Country
Italy
Facility Name
Azienda Ospedale Università di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 EV
Country
Netherlands
Facility Name
Radboud University Medical Centre Nijmegen
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Auditory Implant Centre, Glan Clwyd Hospital
City
Bodelwyddan
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 OQT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Learn more about this trial

Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

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