Trial Outcomes & Findings for Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users (NCT NCT01892007)

NCT ID: NCT01892007

Last Updated: 2020-10-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

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

Results posted on

2020-10-01

Participant Flow

Participant milestones

Participant milestones
Measure
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. Cogmed RM - Online adaptive working memory training intervention
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Overall Study
STARTED
27
30
Overall Study
COMPLETED
27
30
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Total
n=57 Participants
Total of all reporting groups
Age, Continuous
66.2 years
STANDARD_DEVIATION 6.3 • n=27 Participants
63.7 years
STANDARD_DEVIATION 5.5 • n=30 Participants
64.9 years
STANDARD_DEVIATION 5.9 • n=57 Participants
Sex: Female, Male
Female
14 Participants
n=27 Participants
16 Participants
n=30 Participants
30 Participants
n=57 Participants
Sex: Female, Male
Male
13 Participants
n=27 Participants
14 Participants
n=30 Participants
27 Participants
n=57 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United Kingdom
27 participants
n=27 Participants
30 participants
n=30 Participants
57 participants
n=57 Participants
Montreal Cognitive Assessment (MoCA) score
27.9 MoCA score
STANDARD_DEVIATION 1.2 • n=27 Participants
28.1 MoCA score
STANDARD_DEVIATION 1.6 • n=30 Participants
28.0 MoCA score
STANDARD_DEVIATION 1.4 • n=57 Participants
BE PTA (0.25-4k Hz)
43.3 decibels
STANDARD_DEVIATION 14.5 • n=27 Participants
37.5 decibels
STANDARD_DEVIATION 12.5 • n=30 Participants
40.2 decibels
STANDARD_DEVIATION 13.7 • n=57 Participants

PRIMARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Visual Letter Monitoring Task
(VLM 2 second) 31 weeks
8.63 score on a scale
Standard Deviation 1.97
Visual Letter Monitoring Task
(VLM 2 second) 0 weeks
8.48 score on a scale
Standard Deviation 1.42
8.27 score on a scale
Standard Deviation 1.89
Visual Letter Monitoring Task
(VLM 2 second) 2 weeks
8.07 score on a scale
Standard Deviation 2.59
8.73 score on a scale
Standard Deviation 1.48
Visual Letter Monitoring Task
(VLM 2 second) 7 weeks
8.33 score on a scale
Standard Deviation 2.04
8.93 score on a scale
Standard Deviation 1.55
Visual Letter Monitoring Task
(VLM 1 second) 0 weeks
5.74 score on a scale
Standard Deviation 2.36
6.67 score on a scale
Standard Deviation 2.50
Visual Letter Monitoring Task
(VLM 1 second) 2 weeks
5.93 score on a scale
Standard Deviation 2.95
6.93 score on a scale
Standard Deviation 2.56
Visual Letter Monitoring Task
(VLM 1 second) 7 weeks
6.73 score on a scale
Standard Deviation 2.01
7.07 score on a scale
Standard Deviation 2.73
Visual Letter Monitoring Task
(VLM 1 second) 31 weeks
6.50 score on a scale
Standard Deviation 2.25

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Phonemic Discrimination Probe
(PD /e/ /a/) 0 weeks
69.98 score on a scale
Standard Deviation 8.97
73.79 score on a scale
Standard Deviation 13.58
Phonemic Discrimination Probe
(PD /e/ /a/) 2 weeks
65.92 score on a scale
Standard Deviation 7.39
68.47 score on a scale
Standard Deviation 11.93
Phonemic Discrimination Probe
(PD /e/ /a/) 7 weeks
69.59 score on a scale
Standard Deviation 11.67
65.20 score on a scale
Standard Deviation 9.58
Phonemic Discrimination Probe
(PD /e/ /a/) 31 weeks
64.96 score on a scale
Standard Deviation 8.39
Phonemic Discrimination Probe
(PD /d/ /g/) 0 weeks
86.44 score on a scale
Standard Deviation 11.26
89.88 score on a scale
Standard Deviation 10.18
Phonemic Discrimination Probe
(PD /d/ /g/) 2 weeks
89.10 score on a scale
Standard Deviation 11.46
87.07 score on a scale
Standard Deviation 12.65
Phonemic Discrimination Probe
(PD /d/ /g/) 7 weeks
90.07 score on a scale
Standard Deviation 11.00
88.40 score on a scale
Standard Deviation 12.09
Phonemic Discrimination Probe
(PD /d/ /g/) 31 weeks
85.67 score on a scale
Standard Deviation 13.63

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
BESST High/Low Context Sentence Intelligibility
BESST (High Context) 0 weeks
31.65 percentage of last words correct
Standard Deviation 23.92
33.23 percentage of last words correct
Standard Deviation 26.07
BESST High/Low Context Sentence Intelligibility
BESST (High Context) 2 weeks
30.18 percentage of last words correct
Standard Deviation 18.47
24.16 percentage of last words correct
Standard Deviation 17.90
BESST High/Low Context Sentence Intelligibility
BESST (High Context) 7 weeks
29.98 percentage of last words correct
Standard Deviation 23.22
29.48 percentage of last words correct
Standard Deviation 21.12
BESST High/Low Context Sentence Intelligibility
BESST (High Context) 31 weeks
22.73 percentage of last words correct
Standard Deviation 21.77
BESST High/Low Context Sentence Intelligibility
BESST (Low Context) 0 weeks
15.65 percentage of last words correct
Standard Deviation 14.51
14.75 percentage of last words correct
Standard Deviation 13.19
BESST High/Low Context Sentence Intelligibility
BESST (Low Context) 2 weeks
21.10 percentage of last words correct
Standard Deviation 16.33
22.90 percentage of last words correct
Standard Deviation 14.09
BESST High/Low Context Sentence Intelligibility
BESST (Low Context) 7 weeks
18.20 percentage of last words correct
Standard Deviation 16.73
18.20 percentage of last words correct
Standard Deviation 13.53
BESST High/Low Context Sentence Intelligibility
BESST (Low Context) 31 weeks
18.66 percentage of last words correct
Standard Deviation 14.61

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Modified Coordinate Response Measure (MCRM)
MCRM 0 weeks
-3.88 decibels
Standard Deviation 4.85
-5.15 decibels
Standard Deviation 5.68
Modified Coordinate Response Measure (MCRM)
MCRM 2 weeks
-4.51 decibels
Standard Deviation 5.66
-6.50 decibels
Standard Deviation 5.66
Modified Coordinate Response Measure (MCRM)
MCRM 7 weeks
-4.69 decibels
Standard Deviation 5.40
-6.76 decibels
Standard Deviation 5.01
Modified Coordinate Response Measure (MCRM)
MCRM 31 weeks
-4.05 decibels
Standard Deviation 4.79

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Digit Span Backwards
Digit Span (BW) 7 weeks
8.76 trials correct
Standard Deviation 2.19
7.83 trials correct
Standard Deviation 2.67
Digit Span Backwards
Digit Span (BW) 0 weeks
6.96 trials correct
Standard Deviation 2.10
7.17 trials correct
Standard Deviation 2.83
Digit Span Backwards
Digit Span (BW) 2 weeks
7.69 trials correct
Standard Deviation 1.78
8.00 trials correct
Standard Deviation 3.06
Digit Span Backwards
Digit Span (BW) 31 weeks
8.82 trials correct
Standard Deviation 2.36

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Distraction) 0 weeks
0.056 seconds
Standard Deviation 0.145
0.038 seconds
Standard Deviation 0.108
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Distraction) 2 weeks
0.013 seconds
Standard Deviation 0.130
0.074 seconds
Standard Deviation 0.131
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Distraction) 7 weeks
0.033 seconds
Standard Deviation 0.144
0.056 seconds
Standard Deviation 0.100
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Distraction) 31 weeks
0.064 seconds
Standard Deviation 0.108
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Conflict Res) 0 weeks
-0.023 seconds
Standard Deviation 0.089
-0.023 seconds
Standard Deviation 0.115
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Conflict Res) 2 weeks
0.017 seconds
Standard Deviation 0.109
0.047 seconds
Standard Deviation 0.105
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Conflict Res) 7 weeks
0.006 seconds
Standard Deviation 0.105
0.051 seconds
Standard Deviation 0.125
Test of Attention in Listening (TAIL)
TAIL (Attend Frequency_Conflict Res) 31 weeks
0.047 seconds
Standard Deviation 0.091
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Distraction) 0 weeks
0.108 seconds
Standard Deviation 0.110
0.108 seconds
Standard Deviation 0.133
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Distraction) 2 weeks
0.108 seconds
Standard Deviation 0.126
0.082 seconds
Standard Deviation 0.115
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Distraction) 7 weeks
0.097 seconds
Standard Deviation 0.140
0.094 seconds
Standard Deviation 0.097
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Distraction) 31 weeks
0.119 seconds
Standard Deviation 0.150
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Conflict Res) 0 weeks
0.1097 seconds
Standard Deviation 0.125
0.095 seconds
Standard Deviation 0.147
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Conflict Res) 2 weeks
0.105 seconds
Standard Deviation 0.134
0.095 seconds
Standard Deviation 0.098
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Conflict Res) 7 weeks
0.136 seconds
Standard Deviation 0.119
0.099 seconds
Standard Deviation 0.081
Test of Attention in Listening (TAIL)
TAIL (Attend Location_Conflict Res) 31 weeks
0.155 seconds
Standard Deviation 0.168

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Test of Everyday Attention Subtests 6 & 7
(TEA 7) 2 weeks
1.11 seconds
Standard Deviation 1.95
1.26 seconds
Standard Deviation 2.98
Test of Everyday Attention Subtests 6 & 7
(TEA 7) 7 weeks
0.80 seconds
Standard Deviation 1.06
0.55 seconds
Standard Deviation 0.78
Test of Everyday Attention Subtests 6 & 7
(TEA 7) 31 weeks
0.81 seconds
Standard Deviation 0.92
Test of Everyday Attention Subtests 6 & 7
(TEA 7) 0 weeks
0.12 seconds
Standard Deviation 3.03
1.26 seconds
Standard Deviation 1.48
Test of Everyday Attention Subtests 6 & 7
(TEA 6) 0 weeks
4.11 seconds
Standard Deviation 3.67
3.35 seconds
Standard Deviation 0.65
Test of Everyday Attention Subtests 6 & 7
(TEA 6) 2 weeks
3.27 seconds
Standard Deviation 0.63
3.23 seconds
Standard Deviation 0.70
Test of Everyday Attention Subtests 6 & 7
(TEA 6) 7 weeks
3.25 seconds
Standard Deviation 0.66
3.00 seconds
Standard Deviation 0.69
Test of Everyday Attention Subtests 6 & 7
(TEA 6) 31 weeks
3.09 seconds
Standard Deviation 0.55

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Size Comparison Span
SICSPAN (intrusions) 0 weeks
4.82 score on a scale
Standard Deviation 3.63
3.20 score on a scale
Standard Deviation 2.33
Size Comparison Span
SICSPAN (total) 0 weeks
20.96 score on a scale
Standard Deviation 6.16
24.40 score on a scale
Standard Deviation 7.82
Size Comparison Span
SICSPAN (total) 2 weeks
24.26 score on a scale
Standard Deviation 7.02
26.27 score on a scale
Standard Deviation 8.31
Size Comparison Span
SICSPAN (total) 7 weeks
25.11 score on a scale
Standard Deviation 7.05
26.43 score on a scale
Standard Deviation 8.16
Size Comparison Span
SICSPAN (total) 31 weeks
24.64 score on a scale
Standard Deviation 6.07
Size Comparison Span
SICSPAN (intrusions) 2 weeks
5.11 score on a scale
Standard Deviation 4.10
3.97 score on a scale
Standard Deviation 3.35
Size Comparison Span
SICSPAN (intrusions) 7 weeks
4.52 score on a scale
Standard Deviation 4.01
410 score on a scale
Standard Deviation 3.68
Size Comparison Span
SICSPAN (intrusions) 31 weeks
5.59 score on a scale
Standard Deviation 4.15

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Dual Task of Listening and Working Memory
Dual Task 31 weeks
20.71 score on a scale
Standard Deviation 5.14
Dual Task of Listening and Working Memory
Dual Task 0 weeks
18.11 score on a scale
Standard Deviation 6.66
18.87 score on a scale
Standard Deviation 5.14
Dual Task of Listening and Working Memory
Dual Task 2 weeks
19.26 score on a scale
Standard Deviation 5.77
20.20 score on a scale
Standard Deviation 6.20
Dual Task of Listening and Working Memory
Dual Task 7 weeks
20.88 score on a scale
Standard Deviation 5.73
22.14 score on a scale
Standard Deviation 5.53

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Hearing Handicap Inventory for the Elderly (HHIE)
HHIE 31 weeks
35.90 score on a scale
Standard Deviation 30.04
Hearing Handicap Inventory for the Elderly (HHIE)
HHIE 0 weeks
40.89 score on a scale
Standard Deviation 27.10
34.07 score on a scale
Standard Deviation 21.36
Hearing Handicap Inventory for the Elderly (HHIE)
HHIE 2 weeks
39.93 score on a scale
Standard Deviation 27.90
30.73 score on a scale
Standard Deviation 23.75
Hearing Handicap Inventory for the Elderly (HHIE)
HHIE 7 weeks
37.19 score on a scale
Standard Deviation 26.84
28.41 score on a scale
Standard Deviation 21.19

SECONDARY outcome

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

Population: Outcome measured at 0, 2, 7 and (adaptive training group only) 31 weeks. Training-related improvements in outcomes are assessed using the change in performance between pre-training (2 weeks) to post-training (7 weeks) measures.

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.

Outcome measures

Outcome measures
Measure
Cogmed RM (Adaptive)
n=27 Participants
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. Cogmed RM - Online adaptive working memory training intervention
Active Control: Cogmed RM (Non-adaptive, Placebo)
n=30 Participants
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. Cogmed RM - Online (non-adaptive, placebo) working memory training intervention
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Initial Disability) 31 weeks
36.84 units on a scale
Standard Deviation 22.77
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Initial Disability) 0 weeks
43.29 units on a scale
Standard Deviation 16.98
35.00 units on a scale
Standard Deviation 15.54
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Initial Disability) 2 weeks
43.98 units on a scale
Standard Deviation 17.80
36.42 units on a scale
Standard Deviation 15.68
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Initial Disability) 7 weeks
38.66 units on a scale
Standard Deviation 20.07
36.88 units on a scale
Standard Deviation 15.77
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Handicap) 0 weeks
35.88 units on a scale
Standard Deviation 26.21
29.38 units on a scale
Standard Deviation 19.91
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Handicap) 2 weeks
34.26 units on a scale
Standard Deviation 28.82
29.31 units on a scale
Standard Deviation 20.46
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Handicap) 7 weeks
30.56 units on a scale
Standard Deviation 29.89
24.38 units on a scale
Standard Deviation 16.93
Glasgow Hearing Aid Benefit Profile (GHABP)
GHABP (Handicap) 31 weeks
30.40 units on a scale
Standard Deviation 28.56

Adverse Events

Cogmed RM (Adaptive)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Control: Cogmed RM (Non-adaptive, Placebo)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Helen Henshaw

NIHR Nottingham Biomedical Research Centre, University of Nottingham

Phone: +44 (0)115 8232606

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place