Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults (CSSAR)
17. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kristina Bowdrie, AuD, PhD
- Telefonnummer: 216-368-0957
- E-post: kab177@case.edu
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve University
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Ta kontakt med:
- Kristina Bowdrie, AuD, PhD
- Telefonnummer: 2163680957
- E-post: kab177@case.edu
-
Ta kontakt med:
- E-post: kab177@case.edu
-
Hovedetterforsker:
- Kristina Bowdrie, AuD, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control Group
No intervention - receives only standard audiological care
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Perceived Hearing Aid Benefit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
17. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY20260791
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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