Anatomy-based Fitting in Unexperienced Cochlear Implant Users

Sponsor

Dominik Riss (Other)

Overall Status

Recruiting

CT.gov ID

NCT05684393

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures	Other: frequency distribution type	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

double blinded design: both the participant and the investigator have no information about the treatment group.

Primary Purpose:

Basic Science

Official Title:

Anatomy-based Fitting in Unexperienced Cochlear Implant Users

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anatomy based fitting	Other: frequency distribution type 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.
Active Comparator: Standard fitting	Other: frequency distribution type 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.

Arm

Intervention/Treatment

Experimental: Anatomy based fitting

Other: frequency distribution type

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.

Active Comparator: Standard fitting

Other: frequency distribution type

Outcome Measures

Primary Outcome Measures

Word recognition score (WRS) [6 months]
Percentage of correctly understood monosyllabic words from a list.

Secondary Outcome Measures

Speech reception threshold (SRT) [6 months]
German matrix sentence test - speech to noise ratio in dB.
Pitch ranking [6 months]
Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.
Perception of timbre [6 months]
Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio.
Phoneme categorization [6 months]
Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.
Consonance/difference rating [6 months]
The degree of modulation of the pleasantness-score across the individual intervals.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1180

Sponsors and Collaborators

Dominik Riss

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominik Riss, Assoc.-Prof. Priv.-Doz. Dr. med., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT05684393

Other Study ID Numbers:

2131/2021

First Posted:

Jan 13, 2023

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Seizures

Study Results

No Results Posted as of Jan 13, 2023