片側性難聴/片耳難聴の子供と成人における人工内耳の安全性と有効性を評価するための調査 (PAS-SSD)
片側性難聴/片耳難聴の小児および成人における人工内耳の安全性と有効性を評価するための承認後、前向き、非無作為化、単腕多施設調査
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Palo Alto、California、アメリカ、94304
- Stanford University
-
-
Colorado
-
Englewood、Colorado、アメリカ、80113
- Rocky Mountain Ear Center
-
-
Iowa
-
Iowa City、Iowa、アメリカ、52242
- University of Iowa
-
-
New York
-
New York、New York、アメリカ、10003
- New York Eye and Ear Infirmary
-
-
North Carolina
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Chapel Hill、North Carolina、アメリカ、27517
- University of North Carolina
-
-
Washington
-
Seattle、Washington、アメリカ、98101
- Virginia Mason Medical Center
-
-
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:
• Individuals 18 years or older (Group A)
Ear to be Implanted:
Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
• Children 5 years to 17 years, 11 months (Group B)
Ear to be Implanted:
Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
- Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
- English spoken as a primary language
- Willing and able to provide written informed consent
Exclusion Criteria:
- Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Previous cochlear implantation
- Hearing loss of neural or central origin, including auditory neuropathy
- Duration of profound sensorineural HL >10 years per self-report
- Active / chronic middle-ear infection; conductive HL in either ear
- Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
- Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
- Evidence of and/or suspected cognitive or developmental concern
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
- Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
- Pregnant or breastfeeding women
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：片耳難聴・片耳難聴の小児・成人
|
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®. |
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 |
|---|---|---|
|
タイプ、頻度、および重症度別に分類された手順およびデバイス関連の有害事象の数。
時間枠：有効化後 36 か月
|
有効化後 36 か月
|
|
|
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
時間枠：pre-implantation, 12 months post-activation
|
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear. |
pre-implantation, 12 months post-activation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
時間枠：pre-implantation, 12 months post-activation
|
Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities. |
pre-implantation, 12 months post-activation
|
|
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
時間枠：pre-implantation, 12 months post-activation
|
Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better. |
pre-implantation, 12 months post-activation
|
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 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CAM5816
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。