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Patient-Oriented Research to Optimize Cochlear Implant Outcomes

2026年6月24日 更新者：Aaron Moberly、Vanderbilt University Medical Center

The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims:

Specific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (> 6 months of CI use).

Specific Aim #2: Determine the feasibility of "auditory" (bottom-up) and "cognitive" (top-down) interventions to improve speech processing in adult CI users.

The main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention.

Additional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Specific Aim 1: Along with collection of demographic/audiologic and datalogging variables, participants will be tested for auditory spectro-temporal resolution and cognitive-linguistic functions. Functional near-infrared spectroscopy (fNIRS) will be collected, reflecting cortical responses to speech.

Using cluster analyses, investigators will test the hypothesis that different profiles exist, with different CI users demonstrating different patterns of bottom-up processing, top-down processing, or both. Patient-reported outcomes of CI-related quality of life, communication, and satisfaction will also be assessed to relate speech recognition to broader real world functioning.

Specific Aim 2: The "auditory" intervention includes a two-pronged approach of, first, verifying fitting via upper stimulation levels shaped to electrically evoked stapedial reflex thresholds (eSRTs) and lower stimulation levels fit to CI-aided detection between 20 and 30 dB Hearing Loss (HL), and second, image-guided cochlear implant programming (IGCIP) to reduce CI channel interaction. The "cognitive" intervention consists of computerized auditory-cognitive training using a well-established home-based training program focused on improving speech recognition through engaging cognitive processes known to be integral for successful listening in challenging conditions.

CI users from Aim #1 will be randomized to one of three groups:

  1. Group 1 receives an auditory intervention followed by a cognitive intervention (AC group);
  2. Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).

研究の種類

介入

入学 (推定)

100

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

研究場所

  • アメリカ
    • Tennessee
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt University Medical Center
        • コンタクト：
        • 主任研究者：
          • Aaron Moberly, MD

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:

  1. Adults between ages of 18 years and 95 years
  2. Native language is American English
  3. Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).
  4. Experience of >6 of CI use.

Exclusion Criteria:

  1. Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia
  2. Known diagnosis of dementia
  3. Under the age of 18 years
  4. Unable to read and write in English (WRAT score <70)
  5. Poorer than 20/40 near vision on near-vision screening.

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：支持療法
  • 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
アクティブコンパレータ：Group 1 - Auditory Intervention (AC)
Those randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training.
行動：AC Group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.

The auditory intervention consists of two in person visits:

Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.

Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.

At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.

行動：CA group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.

Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.

Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.

At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
アクティブコンパレータ：Group 2 - Cognitive Intervention (CA)
Those randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training.
行動：AC Group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.

The auditory intervention consists of two in person visits:

Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.

Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.

At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.

行動：CA group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.

Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.

Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.

At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
介入なし：Group 3 - Control
Group 3 will be the control group and not receive either training.

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
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.
時間枠：at ~8 weeks study completion
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. This score is from 0 to 100% words correct.
at ~8 weeks study completion

二次結果の測定

結果測定
メジャーの説明
時間枠
Cochlear Implant Quality of Life (CIQOL-35)
時間枠：at ~8 weeks study completion
This measures assesses six domains: communication, emotional, entertainment, environment, listening effort, and social. Each domain is scored between 0 and 100 points.
at ~8 weeks study completion

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

Vanderbilt University Medical Center

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7月1日

一次修了 (推定)

2031年6月1日

研究の完了 (推定)

2032年6月1日

試験登録日

最初に提出

2026年5月9日

QC基準を満たした最初の提出物

2026年6月24日

最初の投稿 (実際)

2026年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 260536

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?

未定

IPD プランの説明

This is a feasibility study. De-identified individual participant data (IPD) collected in this study may be available to other researchers (e.g., outside the primary research group) Data may be shared with others if requested and necessary agreements are made. This is still undecided as this is a feasibility trial.

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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

いいえ

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