Strengthening the Ear-to-brain Connection in Older Adults With Hearing Loss Through Engaging Web-based Gamified Auditory-cognitive Dual-task Training: a Randomized Controlled Trial
Abstract Objectives To assess the effectiveness of a web-based gamified auditory-cognitive dual-task training (ACDT) in improving the everyday listening abilities of older adults with hearing loss (HL), including speech perception performance, cognition, and self-reported hearing.
Hypothesis to be tested ACDT participants will show significantly greater improvements in 1) self-reported hearing; 2) speech perception-in-noise; 3) attention; 4) reasoning; and 5) dual-task of listening and working memory compared to the control group at week 6, immediately post-intervention, and week 24.
Design and subjects A prospective, single-blinded, two-arm parallel randomized controlled trial with individual semi-structured interviews. 164 Chinese adults aged 60 years or older, who speak Cantonese or Putonghua, and have mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.
Study instruments A web-based gamified auditory-cognitive dual-task training. Interventions This is a 12-week program conducted five times a week, with each session lasting 60 minutes, following a sequential dual-task training design. Each session includes auditory training in speech-in-noise, rapid speech, and competing speaker, and cognitive training focusing on executive function, perceptual-motor ability, memory, and complex attention.
Main outcome measures Self-reported hearing (untrained); Speech perception in noise (trained), attention in listening and sustained selective attention (trained), reasoning (trained), and dual-task of listening and working memory; complex span working memory (trained).
Data analysis Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.
Expected results ACDT significantly improves the everyday listening abilities of older adults with HL.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ivy Yan Zhao
- Numero di telefono: +8527664550
- Email: yan-ivy.zhao@polyu.edu.hk
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Ethnic Chinese aged 60 years and above, who speak Cantonese or Putonghua;
- Mild-to-moderate peripheral hearing loss diagnosed by a pure-tone average of 20-50 dB across octave frequencies of 0.5-4kHz in both ears;
- Not using hearing aids;
- Sensorineural hearing loss (defined as an air-bone gap across 0.5, 1, and 2 kHz<15 dB); and 5) No cognitive impairment [score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)].
Exclusion Criteria:
- Previously took part in a training intervention study;
- Diagnosed with a major neurocognitive disorder;
- A history of symptomatic stroke or other disease of the central nervous system; speech/ language disorders;
- A serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with engaging in web-based training.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: A web-based gamified auditory-cognitive sequential dual-task training
A web-based gamified auditory-cognitive sequential dual-task training (ACDT) will be provided to participants.
Each participant will receive a 12-week program conducted five times a week, with each session lasting 60 minutes, following a sequential dual-task training design.
|
The intervention is a 12-week sequential dual-task training program delivered five times per week for 60 minutes per session.
Each session includes 5 minutes of volume adjustment and orientation exercises, 25 minutes of adaptive auditory training in speech-in-noise, rapid speech, and competing-speaker listening, 25 minutes of culturally tailored cognitive games targeting executive function, memory, attention, and perceptual-motor skills, and a 5-minute wrap-up with communication strategies and long-term memory recall.
The program uses real-life scenarios, individualized difficulty adjustment, audiovisual guidance, and gamified features such as praise, fireworks, likes, and leaderboards to enhance engagement.
|
|
Comparatore placebo: Crossword puzzles control group
Participants will be instructed to complete web-based Chinese crossword puzzles 60 minutes per day and five days a week.
|
Participants will be instructed to complete web-based Chinese crossword puzzles 60 minutes per day and five days a week.
Medium difficulty level will be selected for participants according to previous research.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hearing Handicap Inventory for the Elderly
Lasso di tempo: at week 6, immediately post-intervention (week 12), and week 24
|
will be measured using the Chinese Hearing Handicap Inventory for the Elderly (HHIE), which is a 25-item validated questionnaire that quantifies the emotional and social/situational effects of self-perceived hearing impairment to quantify hearing-related quality of life.
|
at week 6, immediately post-intervention (week 12), and week 24
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The Cantonese Hearing in Noise Test
Lasso di tempo: at week 6, immediately post-intervention (week 12), and week 24
|
a standardized Cantonese sentence speech-intelligibility test, assesses speech reception thresholds for sentences in quiet and in spatially simulated noise presented from the front, right, or left.
It has demonstrated low within-list response variability and high inter-list reliability, with normative results comparable to those of the English Hearing in Noise Test.
|
at week 6, immediately post-intervention (week 12), and week 24
|
|
The Chinese Auditory Verbal Learning Test
Lasso di tempo: at week 6, immediately post-intervention (week 12), and week 24
|
The Chinese Auditory Verbal Learning Test (AVLT), which assesses multiple cognitive domains including immediate recall, learning efficiency, delayed recall, retention rate, and recognition memory, and has demonstrated high test-retest reliability (ICC=0.79-0.82)
and 78% sensitivity;
|
at week 6, immediately post-intervention (week 12), and week 24
|
|
The Chinese Trial Making Test Part A& B
Lasso di tempo: at week 6, immediately post-intervention (week 12), and week 24
|
The Chinese Trial Making Test Part A& B (TMT A&B), which measures visual attention, processing speed, and executive function, and has shown strong discriminant validity (d=1.2 for vascular dementia)
|
at week 6, immediately post-intervention (week 12), and week 24
|
|
Dual task of listening and working memory
Lasso di tempo: at week 6, immediately post-intervention (week 12), and week 24
|
complex span working memory (trained): Participants are shown a string of five digits for 5 seconds to memorize for later recall.
They then hear a list of five AB isophonemic monosyllabic CVC words (e.g., ship, rug, rail) in ICRA 6-talker babble at a 0 dB signal-to-noise ratio and must repeat each word immediately.
After each word list, they recall the five digits.
|
at week 6, immediately post-intervention (week 12), and week 24
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 23240731
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .