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

September 9, 2020 updated by: Nottingham University Hospitals NHS Trust

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG1 5DU
        • QMC Ropewalk House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Letter Monitoring Task
Time Frame: 0, 2, 7, and (adaptive training group only) 31 weeks
The VLM is a visual task of working memory (Gatehouse, Naylor, & Elberling, 2006) that is not trained within the Cogmed working memory training program. Ten consonant-vowel-consonant (CVC) words are embedded in an 80-letter sequence. Two sequences are presented to participants at each outcome assessment in a counterbalanced order. Individual letters are displayed sequentially on a computer screen at a rate of 2 second per letter (first list) and 1 second per letter (second list). Participants were asked to press the keyboard 'space bar' (hit) when three consecutive letters formed a recognised CVC word (for example, M-A-T). Task performance was scored as the total number of hits (maximum score of ten per list). Higher scores indicate better performance.
0, 2, 7, and (adaptive training group only) 31 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phonemic Discrimination Probe
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The phoneme discrimination task assesses an individual's ability to distinguish differences between phonemes presented on a continuum. Participants were presented with three discrete phonemes per trial from a continuum of 96 sound files (48 for each phoneme within a pair). For each trial, two of the phonemes were identical and one was different. Participants were asked to identify the odd one out. Two different phoneme pairs: /a/ /e/ (easy) and /d/ /g/ (difficult) were presented for a block of 35 trials in sequential blocks, with a 3-trial demonstration of continuum /a/ /e/. The task was presented in quiet room and difficulty was adapted based on individual participant performance using a three-phase adaptive staircase procedure (Moore, 2005) to provide a phoneme discrimination threshold, which is calculated as the average distance between the 96 sound files for the last 2 reversals in a block of 35 trials. Scores range from 50-100, with lower scores indicating better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
BESST High/Low Context Sentence Intelligibility
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
Based on the Revised Speech Perception in Noise Test (Bilger et al, 1984; Kalikow et al, 1977), the British English Semantic Sentence Test (BESST) stimuli are produced by a British English native speaker. Lists of 22 sentences (11 high-predictability and 11 low-predictability) were presented in the freefield in a background of speech-modulated noise with the same long-term average spectrum as the target speech (Knight, 2017), at a fixed signal-to-noise ratio (SNR) of -1 decibel (dB) SNR. Two practice sentences (one high- and one low-predictability) were presented to participants at a slightly more favourable fixed SNR (2 dB SNR) prior to commencing the main test. Participants were asked to listen to each sentence and repeat the last word aloud. The task was scored as the percentage of last words correctly repeated for both high-predictability and low-predictability lists. Higher scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Modified Coordinate Response Measure (MCRM)
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The MCRM is a measure of target talker speech perception in the presence of another talker, presented at an adaptive signal-to-noise ratio (SNR). Participants were presented with sentences in the form of 'show the [animal] where the [color] [number] is'. Participants were asked to listen for the color and number spoken by the female speaker ('dog' was always the animal target) while ignoring the male speaker, and respond by pressing the corresponding target color number on a touchscreen computer. The test used an adaptive 1-up 1-down staircase method and continued until a total of eight reversals were achieved. The test was completed twice by each participant and a third time for instances where there was a difference of ≥5 decibel (dB) SNR between participants' first two test scores. Speech reception thresholds were calculated using the average of the last two reversals, averaged across the 2 or 3 tests. Lower scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Digit Span Backwards
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
A subtest from the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III) (Wechsler, 1997), this task involved listening to a string of numbers of increasing length and repeating them in reverse order. The test was presented using pre-recorded digits delivered using the Medical Research Council (MRC) Institute of Hearing Research System for Testing Auditory Responses (IHR-STAR) platform via a speaker situated directly in front of the participant. Trials began with strings of two numbers, finishing at strings of eight. Each string length was presented twice. Strings increased in length by one digit if participants correctly recalled one of the two digit strings at each length, otherwise the test was discontinued. Task performance was scored as the total number of strings correctly recalled in reverse order (of a maximum 14 trials). Higher scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Test of Attention in Listening (TAIL)
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The Test of Attention in Listening (TAIL) is a measure of auditory attention using tones that vary in both frequency and spatial location (Zhang et al., 2012). Primary tasks included both frequency and location discrimination and participants were asked to respond as to whether two tones were the 'same' or 'different' in terms of either frequency or location . Tones were presented in the freefield at participants' most comfortable loudness (MCL) level (Ventry et al., 1971) via two speakers situated at 90° to the left and 90° to the right of the participant at a distance of 50cm. TAIL measures the ability to focus selectively on a task-relevant dimension (either frequency or location) and ignore information from task-irrelevant dimensions, using reaction time (RT) as the primary performance measure. This test produced two measures per condition (frequency and location), calculated from the RT data; Distraction and Conflict Resolution. Lower scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Test of Everyday Attention Subtests 6 & 7
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The Test of Everyday Attention (TEA) subtests 6 (telephone search) and 7 (telephone search while counting) assess single (visual) attention and dual (auditory and visual) attention (Robertson, Ward, Ridgeway, & Nimmo-Smith, 1994). For subtest 6, participants were asked to search a telephone directory for matching symbols. For subtest 7, participants were asked to search a telephone directory for matching symbols while counting strings of beeps in varying lengths (2 to 12) presented in the freefield. The task as scored using time (seconds) per correctly identified symbol, weighted in subtest 7 by the proportion of correctly counted beep strings. A dual task decrement was calculated as the difference in time (in seconds) per correctly identified symbol where two simultaneous tasks are being completed, compared with that for a single task (subtest 7 minus subtest 6). Lower scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Size Comparison Span
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The size-comparison span (SICSPAN) task (Sorqvist, Ljungberg, & Ljung, 2010) asked participants to view lists of size comparisons (e.g. 'tree is larger than acorn') and respond 'yes' or 'no' using a button box. Participants were then provided with to-be-remembered words from the same semantic category (e.g. 'leaf'). At the end of the list, participants were required to recall the to-be-remembered words while inhibiting words included in the size comparison judgments. The task began with lists of 2 size comparison judgments and to-be-remembered words, increasing to list lengths of 3, 4, 5 and 6. There were two trials at each list length. The task continued until all list lengths had been presented, with no discontinuation rule. The task was scored using the number of list items correctly recalled (maximum 40). A second measure (intrusions) recorded the number of incorrect items recalled, or errors in inhibition, for each participant. Higher scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Dual Task of Listening and Working Memory
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The dual task is a measure of listening and memory designed to assess listening effort (Howard, Munro, & Plack, 2010). Participants were presented with a 5-digit memory task that flanked a speech-in-noise comprehension task. A string of 5 digits was displayed visually on a computer screen for 5 seconds. Participants were asked to retain the digits in memory for later recall. Participants were then presented with a list of 5 Arthur Boothroyd (AB) isophonemic monosyllabic words (Boothroyd, 1968) presented in multi-talker babble, and were asked to repeat each word immediately after presentation. After each list of five words, participants were asked to recall the previously presented five digits. There were 4 word lists, resulting in a maximum possible score of 20 correctly repeated words and 20 correctly recalled digits. A dual-task score was calculated by adding together the scores for the word and digit tasks (maximum 40). Higher scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Hearing Handicap Inventory for the Elderly (HHIE)
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The Hearing Handicap Inventory for the Elderly is a 25-item validated questionnaire that quantifies the emotional and social/situational effects of self-perceived hearing impairment to quantify hearing-specific quality of life. Participants were asked to complete the 25-item paper questionnaire answering statements such as 'Does a hearing problem cause you to be nervous' with either 'yes' (4 points), 'no' (0 points) or 'sometimes' (2 points). The questionnaire was scored as total points for all items (maximum 100 points). Subtotal scores can also be derived for emotional (12 items, maximum 48 points) and situational item subscales (13 items, maximum 52 points). Lower scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks
Glasgow Hearing Aid Benefit Profile (GHABP)
Time Frame: 0, 2, 7 and (adaptive training group only) 31 weeks
The Glasgow Hearing Aid Benefit Profile (GHABP) is a validated questionnaire to assess self-reported activity limitations (GHABP Initial Disability) and participation restrictions (GHABP Handicap) arising from difficulties in hearing, as well as hearing aid use, benefit, and satisfaction (Gatehouse, 1999). For the purposes of the present study population (experienced hearing aid users) only the first two measures were assessed. Participants were presented with four listening scenarios and were asked to rate the amount of difficulty they have in that situation while wearing their hearing aids (1 = no difficulty to 5 = cannot manage at all), together with how much any difficulty either worried, annoyed or upset them ( 1 = not at all to 5 = very much indeed). The mean of all four scenarios in each measure were converted to a percentage score for GHABP Initial Disability and GHAPB Handicap. Lower scores indicate better performance.
0, 2, 7 and (adaptive training group only) 31 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nottingham University Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Health Research, United Kingdom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08ET002-01

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