Clinical trial NCT01892007: Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing loss
Hearing aid
Speech intelligibility
Speech perception
Cognitive training
Working memory
Working memory training
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2013-07-03
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Visual Letter Monitoring Task
timeFrame: 0, 2, 7, and (adaptive training group only) 31 weeks
Secondary outcomes:
measure: Phonemic Discrimination Probe
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: BESST High/Low Context Sentence Intelligibility
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Modified Coordinate Response Measure (MCRM)
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Digit Span Backwards
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Test of Attention in Listening (TAIL)
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Test of Everyday Attention Subtests 6 & 7
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Size Comparison Span
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Dual Task of Listening and Working Memory
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
measure: Glasgow Hearing Aid Benefit Profile (GHABP)
timeFrame: 0, 2, 7 and (adaptive training group only) 31 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: QMC Ropewalk House
state: Nottinghamshire
Study officials:
affiliation: NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham.
name: Helen Henshaw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham.
name: Melanie Ferguson, BSc (Hons)
role: STUDY_DIRECTOR
References:
citation: Henshaw H, Heinrich A, Tittle A, Ferguson M. Cogmed Training Does Not Generalize to Real-World Benefits for Adult Hearing Aid Users: Results of a Blinded, Active-Controlled Randomized Trial. Ear Hear. 2022 May/Jun;43(3):741-763. doi: 10.1097/AUD.0000000000001096.
citation: 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.