The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
2026년 7월 17일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Antwerp, 벨기에, 2650
- 모병
- Antwerp University Hopsital
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연락하다:
- Emilie Heuninck
- 전화번호: 00324368422
- 이메일: emilie.heuninck@uza.be
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Speech perception in noise
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pitch ranking
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Griet Mertens, Prof., University Hospital, Antwerp
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 6월 26일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 7월 9일
QC 기준을 충족하는 최초 제출
2026년 7월 9일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-7636
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .