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临床试验/NCT01892007
NCT01892007已完成不适用

Evaluation of Cogmed Working Memory Training to Improve Cognition, Speech Perception and Self-reported Hearing Abilities for Adult Hearing Aid Users: a Double-blind, Randomised, Active-controlled Trial.

Nottingham University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Visual Letter Monitoring Task

研究概览

简要总结

A double-blind randomised active-controlled trial aims to assess whether Cogmed (adaptive) working memory training results in improvements in untrained measures of cognition, speech perception and self-reported hearing abilities in older adults (50-74 years) with mild-moderate hearing loss who are existing hearing aid users, compared with an active placebo Cogmed (non-adaptive) control. It is hypothesised that improvements on trained Cogmed tasks, representing increased working memory capacity, will result in improved performance on cognitive and speech perception tasks that engage working memory. We also measure self-reported hearing ability to assess self-perceived benefit of Cogmed training.

详细描述

One in ten people aged between 55-74 years have a significant hearing impairment in their better hearing ear (as defined by audiometric hearing thresholds). Yet, it is becoming increasingly clear that the challenges faced by older listeners cannot be explained by the audiogram. The ability for people with hearing loss to use cognition to support context allows for compensation of degraded auditory input, which in turn offers promise for new cognitive-based rehabilitative interventions. Working memory is known to be highly associated with language and recent evidence has shown significant generalisation of on-task learning from Cogmed working memory training to improvements in sentence-repetition skills of children with severe to profound hearing loss and use cochlear implants. This evidence offers support for further investigation into the potential benefits of working memory training to improve speech perception abilities in other hearing impaired populations. This study aims to assess whether Cogmed (adaptive) working memory training improves the listening abilities of adults with mild to moderate hearing loss as assessed using untrained measurers of cognition, speech perception and self-reported hearing ability, compared with an active control (Cogmed, non-adaptive) group. A 6 month follow-up will assess retention of any training-related improvements in outcomes for the adaptive training group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Blinding

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Existing (3+ months) hearing aid(s) user
  • •Mild to moderate (PTA0.25-4k Hz 21-69 dB HL) sensorineural hearing loss (SNHL) in the better hearing ear (SNHL defined as air-bone gap across 0.5k, 1k & 2k Hz < 15 dB)
  • •Internet access at home

排除标准

  • •Participation in a previous training intervention study
  • •First language other than English (all speech outcome measure are presented in English)
  • •Unable to use either a desktop or laptop computer (Cogmed RM working memory training is delivered via the internet using a desktop or laptop computer)
  • •Cognitive impairment as defined as a score of less than 26/30 (fail) on the Montreal Cognitive Assessment (MoCA)

研究组 & 干预措施

Cogmed RM (adaptive)

Experimental

Online training intervention: An adaptive version of Cogmed RM working memory training. Task difficulty (number of to-be-remembered items) increases based on individual performance, in order to maintain average daily performance levels of approximately 60% of trials correct. Participants complete 35-45 minutes of active training per day, 5 days a week for 5 weeks.

干预措施: Cogmed RM - Online adaptive working memory training (Behavioral)

Cogmed RM (non-adaptive, placebo)

Placebo Comparator

Online training intervention: A non-adaptive placebo version of Cogmed RM working memory training. Tasks are fixed at a low-difficulty practice level (three to-be-remembered items) and do not increase in difficulty over the course of the intervention. Participants complete 35-45 minutes of active placebo training per day, 5 days a week for 5 weeks.

干预措施: Cogmed RM - Online non-adaptive (placebo) working memory training (Behavioral)

结局指标

主要结局

Visual Letter Monitoring Task

时间窗: 0, 2, 7, and (adaptive training group only) 31 weeks

The VLM is a visual task of working memory (Gatehouse, Naylor, \& Elberling, 2006) that is not trained within the Cogmed working memory training program. Ten consonant-vowel-consonant (CVC) words are embedded in an 80-letter sequence. Two sequences are presented to participants at each outcome assessment in a counterbalanced order. Individual letters are displayed sequentially on a computer screen at a rate of 2 second per letter (first list) and 1 second per letter (second list). Participants were asked to press the keyboard 'space bar' (hit) when three consecutive letters formed a recognised CVC word (for example, M-A-T). Task performance was scored as the total number of hits (maximum score of ten per list). Higher scores indicate better performance.

次要结局

  • Test of Everyday Attention Subtests 6 & 7(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Modified Coordinate Response Measure (MCRM)(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Size Comparison Span(0, 2, 7 and (adaptive training group only) 31 weeks)
  • BESST High/Low Context Sentence Intelligibility(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Glasgow Hearing Aid Benefit Profile (GHABP)(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Phonemic Discrimination Probe(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Test of Attention in Listening (TAIL)(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Hearing Handicap Inventory for the Elderly (HHIE)(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Digit Span Backwards(0, 2, 7 and (adaptive training group only) 31 weeks)
  • Dual Task of Listening and Working Memory(0, 2, 7 and (adaptive training group only) 31 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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