Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users (TEACH2)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Detailed Description:

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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.	Behavioral: Cogmed RM - Online adaptive working memory training intervention
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.	Behavioral: Cogmed RM - Online (non-adaptive, placebo) working memory training intervention

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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
2. 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)
3. 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
4. Change in Digit Span Backwards score [ Time Frame: Baseline, 2, 7 and (adaptive training group only) 31 weeks ]
   Trained validated digit recall (backwards) task
5. 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)
6. 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
7. 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
8. 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
9. 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
10. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 74 Years (Adult, Senior)
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)

Contacts and Locations

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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.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Henshaw H, Ferguson MA. Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial. Trials. 2013 Dec 5;14:417. doi: 10.1186/1745-6215-14-417.

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
Last Update Posted:	November 11, 2014
Last Verified:	November 2014

Keywords provided by Nottingham University Hospitals NHS Trust:

Hearing loss; Hearing aid; Speech intelligibility; Speech perception	Cognitive training; Working memory; Working memory training

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases	Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms