Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults (CSSAR)
2026년 7월 17일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kristina Bowdrie, AuD, PhD
- 전화번호: 216-368-0957
- 이메일: kab177@case.edu
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve University
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연락하다:
- Kristina Bowdrie, AuD, PhD
- 전화번호: 2163680957
- 이메일: kab177@case.edu
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연락하다:
- 이메일: kab177@case.edu
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수석 연구원:
- Kristina Bowdrie, AuD, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control Group
No intervention - receives only standard audiological care
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Self-Perceived Hearing Aid Benefit
기간: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 7월 17일
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
2026년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 17일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- STUDY20260791
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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