Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users

NCT ID: NCT01892007

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-10-31

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cogmed RM - Online adaptive working memory training

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Cogmed RM - Online non-adaptive (placebo) working memory training

Intervention Type: BEHAVIORAL

Interventions

Cogmed RM - Online adaptive working memory training

Intervention Type: BEHAVIORAL

Cogmed RM - Online non-adaptive (placebo) working memory training

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Henshaw, PhD

Role: PRINCIPAL_INVESTIGATOR

NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham.

Melanie Ferguson, BSc (Hons)

Role: STUDY_DIRECTOR

NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham.

Locations

QMC Ropewalk House

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34524150 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24304745 (View on PubMed)

Other Identifiers

08ET002-01

Identifier Type: -

Identifier Source: org_study_id