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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ivy Yan Zhao
- 電話番号：+8527664550
- メール：yan-ivy.zhao@polyu.edu.hk
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hearing Handicap Inventory for the Elderly
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Cantonese Hearing in Noise Test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 23240731
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。