Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users (TEACH2)
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| ClinicalTrials.gov Identifier: NCT01892007 |
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Recruitment Status :
Completed
First Posted : July 3, 2013
Last Update Posted : November 11, 2014
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Sponsor:
Nottingham University Hospitals NHS Trust
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hearing Loss | Behavioral: Cogmed RM - Online adaptive working memory training intervention Behavioral: Cogmed RM - Online (non-adaptive, placebo) working memory training intervention | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | 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. |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | October 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Nonsyndromic hearing loss
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cogmed RM (adaptive)
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.
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Behavioral: Cogmed RM - Online adaptive working memory training intervention |
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Placebo Comparator: Active control: Cogmed RM (non-adaptive, placebo)
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.
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Behavioral: Cogmed RM - Online (non-adaptive, placebo) working memory training intervention |
Primary Outcome Measures :
- Change in Visual Letter Monitoring Task score [ Time Frame: Baseline, 2, 7, and (adaptive training group only) 31 weeks ]Untrained visual task of verbal working memory (memory updating)
Secondary Outcome Measures :
- Change in phonemic discrimination ability [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Untrained 3I-3AFC oddball paradigm phonemic discrimination task with 11 phoneme contrast pairs
- Change in high/low context sentence intelligibility [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Recently developed high/low context sentence in noise task (untrained)
- Change in performance on the Modified Coordinate Response Measure [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Untrained 2-competing speaker speech perception task
- Change in Digit Span Backwards score [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Trained validated digit recall (backwards) task
- Change in Test of Attention in Listening (TAIL) score [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Recently developed auditory attention task (untrained)
- Change in score for the Test of Everyday Attention subtests 6 and 7 [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Untrained validated measure of single and divided attention
- Change in Size Comparison score [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Untrained measure of working memory and executive control of semantic confusion
- Change in dual task score (listening and memory) [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Untrained dual task measure of word repetition and digit recall
- Change in self-reported hearing handicap on the Hearing Handicap Inventory for the Elderly (HHIE) [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Validated questionnaire to assess self-reported hearing handicap
- Change in scores on the Glasgow Hearing Aid Benefit Profile (GHABP) [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]Validated questionnaire to assess self-reported hearing disability, hearing handicap, and hearing aid use, benefit and satisfaction
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| Ages Eligible for Study: | 50 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892007
Locations
| United Kingdom | |
| QMC Ropewalk House | |
| Nottingham, Nottinghamshire, United Kingdom, NG1 5DU | |
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
| Principal Investigator: | Helen Henshaw, PhD | NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham. | |
| Study Director: | Melanie Ferguson, BSc (Hons) | NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nottingham University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01892007 History of Changes |
| Other Study ID Numbers: |
08ET002-01 |
| First Posted: | July 3, 2013 Key Record Dates |
| Last Update Posted: | November 11, 2014 |
| Last Verified: | November 2014 |
Keywords provided by Nottingham University Hospitals NHS Trust:
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Hearing loss Hearing aid Speech intelligibility Speech perception |
Cognitive training Working memory Working memory training |
Additional relevant MeSH terms:
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Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |