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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Nottingham University Hospitals NHS Trust
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01892007
First received: June 27, 2013
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Nottingham University Hospitals NHS Trust:

Primary Outcome Measures:
  • Change in Visual Letter Monitoring Task score [ Time Frame: Baseline, 2, 7, and (adaptive training group only) 31 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Validated questionnaire to assess self-reported hearing disability, hearing handicap, and hearing aid use, benefit and satisfaction


Estimated Enrollment: 62
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892007

Contacts
Contact: Helen Henshaw, PhD +44(0)115 8232606 helen.henshaw@nottingham.ac.uk
Contact: Melanie Ferguson, BSc (Hons) +44(0)115 8232600 nhbru-enquiries@nottingham.sc.uk

Locations
United Kingdom
QMC Ropewalk House Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG1 5DU
Contact: Helen Henshaw, PhD    +44(0)115 8232600    nhbru-enquiries@nottingham.ac.uk   
Principal Investigator: Helen Henshaw, PhD         
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

No publications provided by Nottingham University Hospitals NHS Trust

Additional 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
Study First Received: June 27, 2013
Last Updated: July 19, 2013
Health Authority: United Kingdom: National Institute for Health Research

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

ClinicalTrials.gov processed this record on July 31, 2014