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Hearing LossTEACH2NCT01892007

Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users

A study testing Cogmed RM - Online adaptive working memory training in people with Hearing Loss, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 74 years
Conditions the study is for
Hearing Loss
What is being tested?
Cogmed RM - Online adaptive working memory training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2012to Oct 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • QMC Ropewalk House

    Nottingham, Nottinghamshire, NG1 5DU

Other trials in United Kingdom

About this study

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.

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.

Read the 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
Being tested
Cogmed RM - Online adaptive working memory training, Cogmed RM - Online non-adaptive (placebo) working memory training
Keywords
Hearing loss, Hearing aid, Speech intelligibility, Speech perception, Cognitive training, Working memory, Working memory training
Medical subject headings
Hearing Loss, Speech Intelligibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cogmed RM - Online adaptive working memory trainingBehavioural

  • Cogmed RM - Online non-adaptive (placebo) working memory trainingBehavioural

Study groups in NCT01892007
Study groupRoleWhat they receive
Cogmed RM (adaptive)ExperimentalOnline 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.
Receives: Behavioral: Cogmed RM - Online adaptive working memory training
Cogmed RM (non-adaptive, placebo)Placebo comparatorOnline 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.
Receives: Behavioral: Cogmed RM - Online non-adaptive (placebo) working memory training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Letter Monitoring Task

    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.

    Measured: 0, 2, 7, and (adaptive training group only) 31 weeks

Secondary outcomes (10)
  1. Phonemic Discrimination Probe

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  2. BESST High/Low Context Sentence Intelligibility

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  3. Modified Coordinate Response Measure (MCRM)

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  4. Digit Span Backwards

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  5. Test of Attention in Listening (TAIL)

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  6. Test of Everyday Attention Subtests 6 & 7

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  7. Size Comparison Span

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  8. Dual Task of Listening and Working Memory

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  9. Hearing Handicap Inventory for the Elderly (HHIE)

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

  10. Glasgow Hearing Aid Benefit Profile (GHABP)

    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.

    Measured: 0, 2, 7 and (adaptive training group only) 31 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01892007
Sponsor's protocol ID
08ET002-01
Acronym
TEACH2
Status last verified
Sep 2020
First submitted
27 Jun 2013
Last updated
1 Oct 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34524150
  • 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.

    PubMed 24304745

Questions about this trial

What is this clinical trial studying?

A study testing Cogmed RM - Online adaptive working memory training in people with Hearing Loss, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Letter Monitoring Task (time frame: 0, 2, 7, and (adaptive training group only) 31 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01892007, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.

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