Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients (SALUTE)
2026年5月6日 更新者：Cochlear
A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.
The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.
Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.
調査の概要
研究の種類
介入
入学 (推定)
26
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。
研究連絡先
- 名前：PRS Specialist
- 電話番号：+61294286555
- メール：cltd-prs-admin@cochlear.com
研究場所
-
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Colorado
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Lone Tree、Colorado、アメリカ、80124
- Denver Research and Technology Lab
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コンタクト：
- PRS Specialist
-
-
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:
- Aged 18 years or older, at time of consent.
- Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.
- At least 18 active electrodes in the test ear.
- At least 6 months experience with a cochlear implant in the test ear.
- Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.
- Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.
- Candidate is a fluent speaker in the language used to assess speech perception performance.
- Direct access to a compatible smartphone.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Recipients with single-sided deafness as determined by the Investigator.
- Additional disabilities that would prevent participation in evaluations.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
- 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 or contractors engaged by Cochlear for the purposes of this investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
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：クロスオーバー割り当て
- 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 |
|---|---|
|
実験的：Veterans
|
While the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing.
This setting will be referred to as SCAN ForwardFocus (SCAN FF).
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.
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実験的：Non-veterans
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While the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing.
This setting will be referred to as SCAN ForwardFocus (SCAN FF).
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.
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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 |
|---|---|---|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration
時間枠：Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S90N180 spatial configuration
時間枠：Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N180 spatial configuration
時間枠：Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in AzBio improvement (percentage-point change) for the Nucleus 8 Sound Processor (SCAN 2 FF minus SCAN 2) compared to the Nucleus 7 Sound Processor (SCAN FF minus SCAN) in the S0N180 spatial configuration
時間枠：Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in CNC percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
時間枠：Week 2 and week 4
|
The consonant-nucleus-consonant (CNC) monosyllabic word test will be used to assess speech perception of words in quiet.
The test consists of 10 recorded lists of 50 monosyllabic words, produced by a male talker.
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Week 2 and week 4
|
|
Paired difference in AzBio percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
時間枠：Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N0 spatial configuration
時間枠：Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Proportion of participants preferring each sound processor in various listening domains
時間枠：Week 4
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The Device Preference Questionnaire is a custom self-assessment to evaluate participants' preference between the Nucleus 8 and Nucleus 7 Sound Processors, or "no preference".
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Week 4
|
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Mean difference in SSQ-12 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
時間枠：Week 2 and Week 4
|
The SSQ-12 is a validated 12-item abbreviated form of the Speech, Spatial, and Qualities of Hearing scale that measures self-reported hearing ability across speech, spatial, and sound quality domains, with each item rated from 0 (poor) to 10 (excellent).
Total scores are calculated by averaging responses across relevant items.
|
Week 2 and Week 4
|
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Mean difference in VFS-A-10 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
時間枠：Week 2 and Week 4
|
The Vanderbilt Fatigue Scale-10-Item Adult (VFS-A-10) is a validated 10-item subjective scale designed to assess listening-related fatigue in adults with hearing loss.
The scale provides a total score based on all 10 questions rated on a Likert scale from 0 (no listening-related fatigue) to 4 (severe listening-related fatigue).
|
Week 2 and Week 4
|
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。
スポンサー
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 (推定)
2026年5月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
はい
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。