Naída CI M90 (Marvel) サウンド プロセッサのリモート評価
Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.
調査の概要
詳細な説明
Within-subject comparison, standard of care CE marked Advanced Bionics device. Remote Evaluation of new CI Naida M sound processor through speech understanding in quiet and noise using standard clinical tests, subjective feedback on sound quality for a set of listening situations reflecting everyday use and a ease of use questionnaire. Two adult groups, one CI users and the other bimodal users. All tests completed remotely.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Cambridge、イギリス、CB2 OQQ
- Cambridge Biomedical Campus, Addenbrookes Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adult Advanced Bionics cochlear implant users due for a sound processor upgrade in line with normal standard of care. Able to access the internet and undertake tests remotely.
説明
Inclusion Criteria:
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CI users with a CI, HiRes90K (Advantage) or HiRes Ultra cochlear implant system
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Unilaterally implanted recipients using only a Naída Q sound processor
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Bimodal users: additionally using hearing aid on their contralateral ear
- Minimum of 18 years of age
- Minimum of five years' experience with their Naída Q sound processor
- Minimum of six months experience with their contralateral hearing aid (if applicable)
- Ability to give feedback on sound quality
- Speech intelligibility with the BKB sentence test in noise at a +10 dB SNR > 10% as obtained during previous visits in the clinical routine or BKB >50% in quiet conditions if noise has previously not been tested
- Fluent in English language
Exclusion Criteria:
- Difficulties additional to hearing impairment that would interfere with the study procedures
- Concurrent participation in any other clinical hearing study
- Not due to have their sound processor upgraded in line with normal clinical procedures
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices
時間枠：12 months
|
Understanding speech in presence of completing noise and quiet testing remotely through use of Gorilla software. This will be done through a percentage score calculated within the Gorilla software. |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech
時間枠：12 months
|
Assessment in quiet, background, speech babble, household noises, traffic noise, cafeteria noise and louder alarm signals.This will be done through a measurement of specific questionnaires. |
12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。