Menu
Not yet recruiting NCT07719114

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

No phase Interventional Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinically Streamlined and Structured Aural Rehabilitation (CSSAR).
Who it may be relevant to
Registry conditions: Hearing Loss. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Benefits of Aural Rehabilitation for Adult Users of Entry-Level Hearing Aids

Overview

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.

Interventions

  • Behavioral Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)
    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 mus

Primary outcome measures

  • Self-Perceived Hearing Aid Benefit [Time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention]
  • Self-Perceived Hearing Handicap [Time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention]
  • Word Recognition in Noise [Time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Case Western Reserve University — Cleveland

Identifiers

NCT: NCT07719114 · STUDY20260791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗