Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults (CSSAR)
2026年7月17日 更新者：Kristina Bowdrie、Case Western Reserve University
Evaluating the Benefits of Aural Rehabilitation for Adult Users of Entry-Level Hearing Aids
The goal of this mixed methods clinical trial is to determine whether a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention improves hearing aid outcomes for new adult users, age 55 years and older, of entry-level hearing aid technology compared with adults who receive standard audiological care.
The main questions are:
- Does the CSSAR intervention result in greater hearing aid benefit, improved aided speech-in-noise performance, and reduced self-perceived hearing handicap among adult users of entry-level hearing aids compared with those who receive standard care, such as a hearing aid evaluation, fitting, and orientation, without a structured aural rehabilitation program?
- How do new adult users of entry-level hearing aids perceive audiological care practices with and without the CSSAR intervention?
Participants will be asked to complete four to five sessions. These sessions may include baseline testing, participation in the CSSAR intervention, two follow-up sessions, and a focus group. For participants in the intervention group, the CSSAR intervention will include a training session with a primary communication partner, followed by use of a mobile auditory training program.
調査の概要
研究の種類
介入
入学 (推定)
60
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：Kristina Bowdrie, AuD, PhD
- 電話番号：216-368-0957
- メール：kab177@case.edu
研究場所
-
-
Ohio
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Cleveland、Ohio、アメリカ、44106
- Case Western Reserve University
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コンタクト：
- Kristina Bowdrie, AuD, PhD
- 電話番号：2163680957
- メール：kab177@case.edu
-
コンタクト：
- メール：kab177@case.edu
-
主任研究者：
- Kristina Bowdrie, AuD, PhD
-
-
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:
- Age 55 and over
- Bilateral, symmetric sensorineural hearing loss
- New users of binaural entry-level Phonak Receiver-in-Canal hearing aids (for experimental control)
- Proficiency in English (in order to understand consent documents, experimental English speech recognition tests, and clinically streamlined and structured aural rehabilitation (CSSAR) trainings)
Exclusion Criteria:
- Score < 23 on cognitive screener
- Unilateral or asymmetric sensorineural hearing loss
- Conductive or mixed hearing loss
- Experienced hearing aid users or users of advanced level hearing aids
- Less than proficient English speaker
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：並列代入
- 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 |
|---|---|
|
介入なし：Control Group
No intervention - receives only standard audiological care
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|
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実験的：Intervention Group
Receives a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard audiological care
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Participants assigned to the intervention group will receive standard of care plus CSSAR.
CSSAR is designed to add more active rehabilitative support (beyond hearing aids) that is feasible for clinical implementation in practice settings.
CSSAR will include two phases.
Phase I CSSAR will consist of a one hour, in-person communication support session delivered prior to the hearing aid fitting.
The participant will be coached through scenarios in which both they and their communication partner must actively reflect on facilitative or maladaptive communication and repair strategies and on environmental modification.
Phase II CSSAR will occur 3 months after the hearing aid fitting, and will consist of auditory training using a free mobile app.
Because structured auditory training is rarely incorporated into routine clinical care, often due to time constraints, this phase is designed to provide an additional rehabilitative element that is accessible and feasible in real-world practice.
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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 |
|---|---|---|
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Self-Perceived Hearing Aid Benefit
時間枠：Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
|
Change in self-perceived hearing aid benefit will be measured using The Abbreviated Profile of Hearing Aid Benefit (APHAB).
The APHAB is a 24-item questionnaire consisting of listening experiences across a range of situations with and without hearing aids.
Participants indicate on a 7-item scale the percentage of time in which the statement is true from Always (99% of the time) to Never (1% of the time) when unaided and when aided with their devices.
The APHAB is a well-used and -accepted clinical questionnaire of perceived hearing aid benefit.
Each item loads onto one of four subscales (Ease of Communication, Background Noise, Reverberation, and Aversiveness).
Benefit is calculated by subtracting the aided average from the unaided average.
The APHAB Benefit score (excluding the Aversiveness subscale) score will be used for analyses, with higher scores suggesting greater benefit.
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Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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Self-Perceived Hearing Handicap
時間枠：Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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Change in self-perceived hearing handicap will be measured using the Revised Hearing Handicap Inventory (R-HHI).
Based on the original Hearing Handicap Inventory for Adults (HHIA) and for the elderly (HHIE), the R-HHI consists of 18 items related to hearing-related aspects of psychosocial health including "Does a hearing problem cause you to feel left out when you are with a group of people."
The respondent is asked to rate each item with "Yes", "Sometimes", and "No", which correspond to scores of 4, 2, and 0 respectively.
Because the R-HHI contains common items across both HHIA and HHIE, it can be used for adults across all ages.
The total score will be used for analyses, with higher scores corresponding to greater perceived hearing handicap.
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Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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Word Recognition in Noise
時間枠：Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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Change in word recognition performance will be measured using the Words in Noise (WIN) Test.
The WIN consists of Northwestern University Auditory Test No. 6 (NU-6) monosyllabic words, a standardized set of phonetically balanced words commonly used to assess speech-recognition ability, presented in the presence of 6-talker babble that is fixed at 80 dB SPL.
There are 35 target words spoken by a female talker within a single list for the WIN, with the signal-to-noise ratio (SNR) decreasing from +24 dB (easiest) to 0 (most difficult) by 4 dB every 5 words.
Following practice, two word lists will be administered and averaged to obtain a total score reflected as percent correct.
WIN Lists 1 and 2 will be counterbalanced across participants and alternated across the follow-up visits to minimize systematic list-order and repeated-exposure.
This total percent of words scored as correct across the two lists will be used for analyses with a higher percentage suggesting better performance.
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Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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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。
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9月1日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年7月17日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月17日
最終確認日
2026年7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
- STUDY20260791
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?
はい
IPD プランの説明
De-identified data may be shared with researchers upon reasonable request, subject to participant consent, institutional approval, and an appropriate data-use agreement.
Aggregate findings, study materials, and analytic code may be shared whenever feasible.
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いいえ
米国FDA規制機器製品の研究
いいえ
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