Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Generalised Speech, Cognitive, and Communication Outcomes

Официальное название

PLUS-Optimal for Adults With Listening Difficulties: Investigating the Roles of Listening and Thinking Skills in Online Training Across Different Groups

Обзор

WP1: PLUS-Auditory Training The goal of this experimental study is to better understand how task difficulty affects on-task learning thresholds and generalised benefits in two PLUS auditory training tasks involving perceptual and cognitive learning in adults aged 18+ (no upper age limit) with listening difficulties. The main question it aims to answer is: * Does adjusting task difficulty in PLUS, by manipulating the perceptual and cognitive demands of the phonemic discrimination and competing speech tasks, affect on-task learning thresholds and off-task performance in adults with listening difficulties? Researchers will compare the two experimental arms (easy/hard) to see whether adjusting task difficulty influences on-task learning thresholds and off-task performance. Participants will: * Be randomly assigned to one of two training programs (phonemic discrimination or competing speech) within the two experimental arms (easy/hard); * Perform training for a minimum of 30 minutes per day, 5 days per week, for two weeks (total 10 training sessions, 5 hours of training); * Complete pre- and post- training assessments to measure on-task learning performance and change in performance for untrained measures of speech perception, cognition and self-reported outcomes. WP2: Post-Training Focus Groups The goal of this observational study is to gain in-depth qualitative insights into participants' motivations, experiences of task difficulty, and perceived benefits across the PLUS-AT training groups in adults aged 18+ (no upper age limit) with listening difficulties. The main question it aims to answer is: * How do participants describe their experiences and perceptions of PLUS-AT, particularly regarding task difficulty and self-perceived changes in listening, hearing, thinking, and quality of life? Researchers will explore participant experiences across the two experimental arms (easy/hard) to determine whether motivations for seeking auditory training, knowledge and beliefs about auditory training, attitudes toward PLUS-AT difficulty, and self-perceived changes in listening, hearing, thinking, and quality of life differ. A subset of participants (n = 20) will: * Be invited from WP1 to join one of four online focus groups (60-90 minutes via Microsoft Teams); * Attend the focus group corresponding to their assigned training program (phonemic discrimination or competing-speech) within the two experimental arms (easy/hard); * Share their experiences of completing PLUS-AT.

Подробное описание

Hearing loss (HL) is a progressive, long-term condition without cure, affecting 18 million people in the UK, which is approximately one in three adults. Globally, HL is the third leading cause of years lived with disability and has major individual, societal, and economic consequences. When unmanaged, HL can lead to communication difficulties, social withdrawal, depression, reduced quality of life, accelerated cognitive decline, and increased dementia risk.

A key challenge reported by people with HL is the difficulty hearing speech in noisy environments, which often persists even when hearing aids (HAs) are used. HAs are the primary management option for HL, but uptake and consistent use is low. Of the 6.7 million people in the UK who could benefit from them, many people do not seek help for their hearing difficulties, and only around 2 million have hearing aids, with non-use estimated to range from 3 to 24%. Therefore, it is essential to develop interventions that can work either as a precursor to or adjacent with HAs to effectively address listening and hearing difficulties.

Auditory training (AT) delivered via internet-accessible devices such as phones or laptops, can be used before or alongside hearing devices such as HAs. As a low-cost intervention, AT supports the self-management of HL and listening difficulties and can be tailored to individual needs. Training itself involves focused listening exercises designed to improve everyday listening, especially in noise. Research shows that AT can improve speech perception throughout an adult's lifespan. It can help individuals improve their ability to distinguish speech in challenging environments like restaurants or family gatherings.

PLUS is a web-based app, standing for Practice Listening and Understanding Speech, developed at the University of Nottingham as an auditory-cognitive training programme. It builds on a decade of research indicating that domain-general improvements in cognitive processing, rather than auditory processing alone, drive the transfer of learning (generalised benefits) to untrained stimuli or tasks. Designed as a cognitively demanding speech training programme, PLUS aims to maximise the transfer of learning to real-world benefits for people with hearing loss. The auditory-cognitive approach was adopted since speech-based tasks are essential for maintaining user motivation and ensuring the training is perceived as relevant to hearing. PLUS has many different settings which changes the task difficulty and influences the level of perceptual and cognitive demand on the learner. It is not known which settings are the most optimal for maximal on-task learning and transfer of learning to everyday listening. The study outlined in this protocol seeks to understand how task difficulty in PLUS affects on-task learning thresholds and generalised benefits in populations with listening difficulties as a first step towards creating an optimal AT intervention for people with HL and self-reported listening difficulties.

Вмешательства

• Поведенческое Practice Listening and Understand Speech (PLUS)
  PLUS is a web-based auditory training platform with two adaptive auditory-cognitive training tasks designed to improve listening and communication. Phonemic Discrimination: Phonemes are sounds (e.g. /ba/ vs /da/) that make words different (e.g. "bad" vs "dad"). Participants hear three sounds (e.g., /ba/, /ba/, /da/) from sound pairs (e.g. /ba/ and /da/), and must identify the sound that's different (/da/). Competing Speech: Two talkers produce similar sentences that differ by keywords. Parti

Первичные конечные точки

• (Adapted) Coordinate Response Measure (CRM) [Срок оценки: Week 1, Week 3]

Вторичные конечные точки (9)

• Practice Listening and Understanding Speech (PLUS) Auditory Training [Срок оценки: Week 1, Week 2]
• Letter N-back [Срок оценки: Week 1, Week 3]
• Flanker Task [Срок оценки: Week 1, Week 3]
• Dual-task of Listening and Memory [Срок оценки: Week 1, Week 3]
• Wisconsin Card Sorting Test (WCST) [Срок оценки: Week 1, Week 3]
• Glasgow Hearing Aid Benefit Profile (GHABP), Part A [Срок оценки: Week 1, Week 3]
• Revised Hearing Handicap Inventory (RHHI) [Срок оценки: Week 1, Week 3]
• Social Participation Restrictions Questionnaire (SPaRQ) [Срок оценки: Week 1, Week 3]
• Digit Triplets Test [Срок оценки: Week 1]

Критерии участия

Критерии включения

• Adults (aged 18+ years, no upper age limit);
• Poorer performance on the DTT (SRT of -5.5 dB SNR or higher, as defined by Dawes, 2013) completed without hearing aid(s) for those who typically use them;
• Non-hearing device users or hearing aid(s) owner;
• Ability to read and understand English;
• Ability to provide informed consent;
• Access to the internet;
• Access to functional built-in speakers, external speakers, or headphones.

Критерии исключения

• Failure to meet inclusion criteria;
• Having previous auditory training experience;
• Cochlear implant users.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• NIHR Nottingham Biomedical Research Centre — Nottingham

Публикации

• Tsimpida D, Rajasingam S, Panagioti M, Henshaw H. The leaky pipeline of hearing care: primary to secondary care evidence from the English Longitudinal Study of Ageing (ELSA). Int J Audiol. 2024 May;63(5):349-357. doi: 10.1080/14992027.2023.2186814. Epub 2023 Mar 23. PMID 36951175
• Oosthuizen I, Manchaiah V, Launer S, Swanepoel W. Hearing aid Experiences of Adult Hearing aid Owners During and After Fitting: A Systematic Review of Qualitative Studies. Trends Hear. 2022 Jan-Dec;26:23312165221130584. doi: 10.1177/23312165221130584. PMID 36300258
• Ferguson MA, Henshaw H, Clark DP, Moore DR. Benefits of phoneme discrimination training in a randomized controlled trial of 50- to 74-year-olds with mild hearing loss. Ear Hear. 2014 Jul-Aug;35(4):e110-21. doi: 10.1097/AUD.0000000000000020. PMID 24752284
• Henshaw H, McCormack A, Ferguson MA. Intrinsic and extrinsic motivation is associated with computer-based auditory training uptake, engagement, and adherence for people with hearing loss. Front Psychol. 2015 Aug 6;6:1067. doi: 10.3389/fpsyg.2015.01067. eCollection 2015. PMID 26300796
• Boothroyd A. Adult aural rehabilitation: what is it and does it work? Trends Amplif. 2007 Jun;11(2):63-71. doi: 10.1177/1084713807301073. PMID 17494873
• Van Wilderode, M. (2019). The implementation and evaluation of different scenarios for a Dutch auditory-cognitive training scheme [Unpublished doctoral thesis]. KU Leuven.
• Stropahl M, Besser J, Launer S. Auditory Training Supports Auditory Rehabilitation: A State-of-the-Art Review. Ear Hear. 2020 Jul/Aug;41(4):697-704. doi: 10.1097/AUD.0000000000000806. PMID 31613823
• Helfer KS, Merchant GR, Wasiuk PA. Age-Related Changes in Objective and Subjective Speech Perception in Complex Listening Environments. J Speech Lang Hear Res. 2017 Oct 17;60(10):3009-3018. doi: 10.1044/2017_JSLHR-H-17-0030. PMID 29049601

Идентификаторы

NCT: NCT07506408 · FMHS 245-0925

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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