- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07730775
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.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Ivy Yan Zhao
- Telefonszám: +8527664550
- E-mail: yan-ivy.zhao@polyu.edu.hk
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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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.
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Placebo Comparator: Crossword puzzles control group
Participants will be instructed to complete web-based Chinese crossword puzzles 60 minutes per day and five days a week.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Hearing Handicap Inventory for the Elderly
Időkeret: at week 6, immediately post-intervention (week 12), and week 24
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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.
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at week 6, immediately post-intervention (week 12), and week 24
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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The Cantonese Hearing in Noise Test
Időkeret: at week 6, immediately post-intervention (week 12), and week 24
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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.
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at week 6, immediately post-intervention (week 12), and week 24
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The Chinese Auditory Verbal Learning Test
Időkeret: at week 6, immediately post-intervention (week 12), and week 24
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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;
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at week 6, immediately post-intervention (week 12), and week 24
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The Chinese Trial Making Test Part A& B
Időkeret: at week 6, immediately post-intervention (week 12), and week 24
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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)
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at week 6, immediately post-intervention (week 12), and week 24
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Dual task of listening and working memory
Időkeret: at week 6, immediately post-intervention (week 12), and week 24
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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.
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at week 6, immediately post-intervention (week 12), and week 24
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 23240731
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