Anatomy-based Fitting in Unexperienced Cochlear Implant U... | NCT05684393

Studies
Anatomy-based Fitting in Unexperienced Cochlear Implant Users

NCT05684393

Sponsor

Dominik Riss

Status

Unknown status

Last Update Posted

Jan 13, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures

Interventions

frequency distribution type

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Jul 2024Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

Jan 4, 2023

First Submission Date that Met QC Criteria

Jan 4, 2023

First Posted Date

Jan 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2023

Last Update Posted Date

Jan 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anatomy based fitting	Experimental		Other: frequency distribution type
Standard fitting	Active Comparator		Other: frequency distribution type

Interventions

Name	Type	Description	Arm Group Labels	Other Names
frequency distribution type	Other	One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Word recognition score (WRS)	Percentage of correctly understood monosyllabic words from a list.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Speech reception threshold (SRT)	German matrix sentence test - speech to noise ratio in dB.	6 months
Pitch ranking	Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
Post-OP CT scan of the CI electrode available
Subject implanted with MED-EL cochlear implant(s)
Subjects received a Flex28, FlexSoft and Standard electrode
Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
Audio processor not yet activated on the newly implanted side
The most apical active electrode contact has to be inserted at least 450°
Minimum of 10 active channels can be activated
Fluent in the language of the test centre
Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

Lack of compliance with any inclusion criteria
EAS user (user of an EAS audio processor)
Implanted with C40+, C40X and C40C
Implanted with an ABI or Split electrode array
Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominik Riss, MD	Contact	+43 1 40400 33760		dominik.riss@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1180	Austria

Intervention Model Description

The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.