Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Zurich
-
Stäfa、Zurich、スイス、8712
- Sonova AG
-
-
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
説明
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Exclusion Criteria:
- Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
アクティブコンパレータ：Sound Processing Principle 1
Sound Processing Principle 1 will be applied in the hearing aid.
|
Compensation of a hearing loss with Sound Processing Principle 1.
|
|
実験的：Sound Processing Principle 2
Sound Processing Principle 2 will be applied in the hearing aid.
|
Compensation of a hearing loss with Sound Processing Principle 2.
|
|
実験的：Sound Processing Principle 3
Sound Processing Principle 3 will be applied in the hearing aid.
|
Compensation of a hearing loss with Sound Processing Principle 3.
|
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 Intelligibility in Noise
時間枠：4 weeks
|
The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test.
The result will be shown in dB (decibel) SRT (Speech Reception Threshold).
|
4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sound Quality - Overall
時間枠：16 weeks
|
The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent). |
16 weeks
|
|
Loudness - Laboratory
時間枠：8 weeks
|
The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test. The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud). |
8 weeks
|
|
Loudness - Daily Life
時間枠：16 weeks
|
The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud). |
16 weeks
|
|
Clarity - Daily Life
時間枠：16 weeks
|
The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear). |
16 weeks
|
|
Preferred Sound Processing Principle
時間枠：16 weeks
|
The preferred sound processing principle will be assessed with the aid of a questionnaire. The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred). |
16 weeks
|
|
Naturalness - Daily Life
時間枠：16 weeks
|
The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural). |
16 weeks
|
|
Localization - Daily Life
時間枠：16 weeks
|
The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable). |
16 weeks
|
|
Reverberation - Daily Life
時間枠：16 weeks
|
The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant). |
16 weeks
|
|
Satisfaction - Overall in Daily Life
時間枠：16 weeks
|
The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied). |
16 weeks
|
協力者と研究者
スポンサー
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。