Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting

NCT04922619 | Completed

• 1 other identifier: MED_EL_tonofit_Rennes_study
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise. Secondary objectives: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of musical elements (contour test). Show the non inferiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of speech elements in quiet. Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the qualitative preference for the listening of musical pieces.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant strategy; tonotopy based fitting

Outcome Measures

Primary Outcomes (2)

• speech recognition in noise

  The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

  at 6 weeks post-activation

• speech recognition in noise

  The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

  at 12 weeks post-activation

Secondary Outcomes (6)

• speech recognition in quiet

  at 6 weeks post-activation

• speech recognition in quiet

  at 12 weeks post-activation

• Melodic contour test

  at 6 weeks post-activation

• Melodic contour test

  at 12 weeks post-activation

• Qualitative measure of music

  at 6 weeks post-activation

Study Arms (2)

Cochlear Implant (CI) with default fitting then tonotopy based fitting

ACTIVE COMPARATOR

Cochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks

Device: tonotopy based fitting then default fitting; Device: default fitting then tonotopy based fitting

Cochlear Implant (CI) with tonotopy based fitting then default fitting

ACTIVE COMPARATOR

Cochlear Implant with tonotopy based fitting during 6 weeks then with default fitting during 6 weeks

Device: tonotopy based fitting then default fitting; Device: default fitting then tonotopy based fitting

Interventions

tonotopy based fitting then default fitting DEVICE

Cochlear implant with default fitting then tonotopy based fitting

Cochlear Implant (CI) with default fitting then tonotopy based fitting; Cochlear Implant (CI) with tonotopy based fitting then default fitting

default fitting then tonotopy based fitting DEVICE

Cochlear implant with tonotopy based fitting then default fitting

Cochlear Implant (CI) with default fitting then tonotopy based fitting; Cochlear Implant (CI) with tonotopy based fitting then default fitting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (\>= 18 years old) speaking French
• Patient who fulfils the criteria for cochlear implantation

You may not qualify if:

• retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
• patient with residual hearing \< 60 dB HL at 250 Hz and \< 80 dB HL at 500 Hz

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU Rennes

Rennes, 35000, France

Location

Related Publications (1)

• Creff G, Bernard-Le Liboux N, Coudert P, Bourdon H, Pean V, Wallaert N, Lambert C, Godey B. Tonotopic and Default Frequency Fitting for Music Perception in Cochlear Implant Recipients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):960-968. doi: 10.1001/jamaoto.2024.2895.

  PMID: 39264640 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benoit Godey, Pr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study: the patient and the investigator don't know the fitting.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two arms A and B: Arm A: patient's fitting with default fitting --\> 6 weeks use --\> tests and patient's fitting with tonotopy based fitting --\> 6 weeks use --\> tests Arm B: patient's fitting with tonotopy based fitting --\> 6 weeks use --\> tests and patient's fitting with default fitting --\> 6 weeks use --\> tests

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 10, 2021
• Study Start: June 10, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)