The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
2026年7月17日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Antwerp、ベルギー、2650
- 募集
- Antwerp University Hopsital
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コンタクト：
- Emilie Heuninck
- 電話番号：00324368422
- メール：emilie.heuninck@uza.be
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Speech perception in noise
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pitch ranking
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Localization
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：12 months post-activation
|
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
時間枠：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
時間枠：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
|
|
HISQUI19 questionnaire
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
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12 months post-activation
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Griet Mertens, Prof.、University Hospital, Antwerp
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年6月26日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年7月9日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月17日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。