Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults (CSSAR)
17 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kristina Bowdrie, AuD, PhD
- Número de teléfono: 216-368-0957
- Correo electrónico: kab177@case.edu
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
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Contacto:
- Kristina Bowdrie, AuD, PhD
- Número de teléfono: 2163680957
- Correo electrónico: kab177@case.edu
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Contacto:
- Correo electrónico: kab177@case.edu
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Investigador principal:
- Kristina Bowdrie, AuD, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control Group
No intervention - receives only standard audiological care
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Perceived Hearing Aid Benefit
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de junio de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY20260791
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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