The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
17 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Antwerp, Belgia, 2650
- Rekrutacyjny
- Antwerp University Hopsital
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Kontakt:
- Emilie Heuninck
- Numer telefonu: 00324368422
- E-mail: emilie.heuninck@uza.be
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny 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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Aktywny 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Speech perception in noise
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pitch ranking
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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6 months post-activation
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Perception of timbre
Ramy czasowe: 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.
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12 months post-activation
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Localization
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.
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6 months post-activation
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Music and cochlear implant questionnaire (MCIQ)
Ramy czasowe: 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.
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12 months post-activation
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HISQUI19 questionnaire
Ramy czasowe: 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
Ramy czasowe: 6 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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6 months post-activation
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HISQUI19 questionnaire
Ramy czasowe: 12 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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12 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Ramy czasowe: 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)
Ramy czasowe: 6 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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6 months post-activation
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Speech, Spatial and Qualities of Hearing scale (SSQ12)
Ramy czasowe: 12 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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12 months post-activation
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Griet Mertens, Prof., University Hospital, Antwerp
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
26 czerwca 2025
Zakończenie podstawowe (Szacowany)
1 grudnia 2027
Ukończenie studiów (Szacowany)
1 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
9 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 lipca 2026
Pierwszy wysłany (Rzeczywisty)
14 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
21 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 lipca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-7636
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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