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

17 juli 2026 bijgewerkt door: 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:

  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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Kristina Bowdrie, AuD, PhD
  • Telefoonnummer: 216-368-0957
  • E-mail: kab177@case.edu

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Case Western Reserve University
        • Contact:
          • Kristina Bowdrie, AuD, PhD
          • Telefoonnummer: 2163680957
          • E-mail: kab177@case.edu
        • Contact:
        • Hoofdonderzoeker:
          • Kristina Bowdrie, AuD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control Group
No intervention - receives only standard audiological care
Experimenteel: Intervention Group
Receives a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard audiological care
Gedragsmatig: 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 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-Perceived Hearing Aid Benefit
Tijdsspanne: 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.
Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Self-Perceived Hearing Handicap
Tijdsspanne: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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.
Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Word Recognition in Noise
Tijdsspanne: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
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.
Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Case Western Reserve University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

17 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

22 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY20260791

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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