The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
17. juli 2026 opdateret af: University Hospital, Antwerp
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients.
Speech perception in noise will be assessed using different spatial configurations of speech and noise.
Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ).
Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Antwerp, Belgien, 2650
- Rekruttering
- Antwerp University Hopsital
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Kontakt:
- Emilie Heuninck
- Telefonnummer: 00324368422
- E-mail: emilie.heuninck@uza.be
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Post-lingual onset of unilateral severe-to-profound sensorineural hearing loss
- Contralateral hearing < 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)
- Post-operative Computed Tomography (CT) scan of the CI elec-trode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex20, Flex24, Flex28, FlexSoft, Flex34 or Standard electrode
- Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side
- Newly implanted CI users
- The most apical active electrode contact has to be inserted at least 540°
- Minimum of 10 active channels can be activated
- Fluent in the language of the test centre
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
Exclusion Criteria:
- Lack of compliance with any inclusion criteria
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Anatomy-based fitting
Anatomy-based programming of the speech processor of the cochlear implant
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Anatomy-based programming of the speech processor of the cochlear implant
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Aktiv komparator: Default fitting
Default programming of the speech processor of the cochlear implant according to standard clinical practice
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Default programming of the speech processor of the cochlear implant according to standard clinical practice
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Speech perception in noise
Tidsramme: 3 months post-activation of the audioprocessor
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Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
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3 months post-activation of the audioprocessor
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Speech perception in noise
Tidsramme: 6 months post-activation of the audioprocessor
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Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
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6 months post-activation of the audioprocessor
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Speech perception in noise
Tidsramme: 12 months post-activation of the audioprocessor
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Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
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12 months post-activation of the audioprocessor
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pitch ranking
Tidsramme: 3 months post-activation
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Frequency difference in semitones between CI and NH
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3 months post-activation
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Pitch ranking
Tidsramme: 6 months post-activation
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Frequency difference in semitones between CI and NH
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6 months post-activation
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Pitch ranking
Tidsramme: 12 months post-activation
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Frequency difference in semitones between CI and NH
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12 months post-activation
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Perception of timbre
Tidsramme: 3 months post-activation
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Score on Visual Analog Scale (VAS).
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
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3 months post-activation
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Perception of timbre
Tidsramme: 6 months post-activation
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Score on Visual Analog Scale (VAS).
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
|
6 months post-activation
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Perception of timbre
Tidsramme: 12 months post-activation
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Score on Visual Analog Scale (VAS).
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
|
12 months post-activation
|
|
Localization
Tidsramme: 3 months post-activation
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Root mean square localization error (RMSE) in degrees
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3 months post-activation
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Localization
Tidsramme: 6 months post-activation
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Root mean square localization error (RMSE) in degrees
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6 months post-activation
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Localization
Tidsramme: 12 months post-activation
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Root mean square localization error (RMSE) in degrees
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12 months post-activation
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Melodic interval perception
Tidsramme: 3 months post-activation
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Psychometric function of melodic intervals
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3 months post-activation
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Melodic interval perception
Tidsramme: 6 months post-activation
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Psychometric function of melodic intervals
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6 months post-activation
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Melodic interval perception
Tidsramme: 12 months post-activation
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Psychometric function of melodic intervals
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12 months post-activation
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Sound quality
Tidsramme: 3 months post-activation
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Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
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3 months post-activation
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Sound quality
Tidsramme: 6 months post-activation
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Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
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6 months post-activation
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Sound quality
Tidsramme: 12 months post-activation
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Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
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12 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Tidsramme: 3 months post-activation
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Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
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3 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Tidsramme: 6 months post-activation
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Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
|
6 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Tidsramme: 12 months post-activation
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Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
|
12 months post-activation
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HISQUI19 questionnaire
Tidsramme: 3 months post-activation
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Total score and classification of self-perceived auditory benefit.
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%).
To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added.
Uncompleted items and the response option "not applicable" correspond to 0 in this calculation.
A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
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3 months post-activation
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HISQUI19 questionnaire
Tidsramme: 6 months post-activation
|
Total score and classification of self-perceived auditory benefit.
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%).
To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added.
Uncompleted items and the response option "not applicable" correspond to 0 in this calculation.
A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
|
6 months post-activation
|
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HISQUI19 questionnaire
Tidsramme: 12 months post-activation
|
Total score and classification of self-perceived auditory benefit.
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%).
To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added.
Uncompleted items and the response option "not applicable" correspond to 0 in this calculation.
A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
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12 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Tidsramme: 3 months post-activation
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Total score and score in the speech, spatial and quality domain.
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items.
For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
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3 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Tidsramme: 6 months post-activation
|
Total score and score in the speech, spatial and quality domain.
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items.
For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
|
6 months post-activation
|
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Tidsramme: 12 months post-activation
|
Total score and score in the speech, spatial and quality domain.
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items.
For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
|
12 months post-activation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Griet Mertens, Prof., University Hospital, Antwerp
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. juni 2025
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
9. juli 2026
Først opslået (Faktiske)
14. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-7636
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