Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07719114
Status
Not Yet Recruiting

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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) — BEHAVIORAL
    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.

Study Details

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: 1. 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? 2. 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.

Key Dates

First listed
Jul 22, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    No intervention - receives only standard audiological care
  • Experimental: Intervention Group
    Receives a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard audiological care

Primary Outcome Measure

Self-Perceived Hearing Aid Benefit [ Time Frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Kristina Bowdrie, AuD, PhD
[email protected]
2163680957
[email protected]
Kristina Bowdrie, AuD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Case Western Reserve University· Cleveland, OH

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