Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000609156
Ethics application status
Approved
Date submitted
8/04/2019
Date registered
23/04/2019
Date last updated
2/03/2021
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of computerised brain training to improve cognitive function in adults with cochlear implants
Scientific title
A randomised controlled trial of auditory-cognitive training for cognition in adults with cochlear implants
Secondary ID [1] 296836 0
None
Universal Trial Number (UTN)
U1111-1225-2963
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderately-severe to profound hearing loss 310741 0
Cognitive function 310742 0
Mood 310744 0
Quality of life 310745 0
Condition category
Condition code
Mental Health 309435 309435 0 0
Studies of normal psychology, cognitive function and behaviour
Ear 309436 309436 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants that meet clinical criteria for a cochlear implant will be recruited into the study. Participants will complete audiometric testing and a speech/sound perception assessment within 12 months preceding surgery and complete the pre-intervention cognitive, mood, and quality of life assessment approximately within 1 week prior to implant. Participants will have the option to complete the pre-intervention assessment in their home or at the Ear Science Institute Australia at a time that is most convenient to them. Following cochlear implant surgery and recovery, participants will attend their ‘switch-on’ appointment where they will be provided with the standardised auditory training material by their implant audiologist. Following ‘switch-on’ appointments, participants will be randomised to either the adaptive or non-adaptive computerised cognitive training (CCT) group and the lead researcher will schedule a time within the same week to visit participant homes to set up the CCT equipment. As the CCT platform, Brain HQ will be delivered via the internet to participant’s home computers and the lead researcher will spend time explaining and demonstrating how to use the platform. Participant adherence to the training will be automatically monitored by the program and remotely by the lead researcher. Participants will be sent regular text messages during the intervention as polite reminders to complete their CCT sessions. Following completion of the training, participants will complete audiometric testing and a post-intervention assessment of their speech/sound perception, cognition, mood, and quality of life. The same outcomes will also be measured at the 3-month follow-up assessment to provide evidence of longer term benefits of CCT.

All participants will complete standardised auditory training following the Adult Cochlear Implant Home-Based Auditory Training Manual – Postlingual Hearing Loss (Henry et al., 2015). Published by Cochlear®, the auditory training manual provides a series of activities of increasing difficulty. Listening activities range from ‘Module 1’ which involves daily practise of listening and identifying environmental sounds (e.g., kettle boiling, phone ringing) to ‘Module 16’ which involves partnered conversations where participants are required to repeat what is heard and most importantly, what is understood, during a conversation (Henry et al., 2015). The auditory training manual also includes instructions for completing computer-based activities via the Angel Sound™ program (Henry et al., 2015). Angel Sound™ is an adaptive auditory training program designed for cochlear implant recipients and involves similar listening activities to those included in the training manual. Participants will be encouraged to use Angel Sound™ in conjunction with the training manual activities. During auditory training participants will be instructed to remove their contralateral hearing aid to maximise use and dependence upon the cochlear implant. Participants will complete the standardised auditory training in line with their treating audiologist’s recommendations, which can vary depending upon each participant’s initial response to their new implant. Auditory training will be completed each week and in addition to the CCT.

The Brain HQ (Posit Science™) program will be used for adaptive CCT. Brain HQ is a commercially available auditory-cognitive training program. To determine whether CCT provides an additive therapeutic effect on study outcomes beyond the standardised auditory training regime, participants will only complete visual CCT activities that target cognitive domains (i.e., Gsm and EF) involved in the successful processing of sound and speech. CCT will therefore place no demand upon a participant’s hearing ability and will not interfere with the standardised post-implant auditory training rehabilitation protocol as recommended by each participant’s implant audiologist. Brain HQ CCT will involve the following activities designed to train each narrow cognitive ability within their corresponding broad domain: (1) ‘Juggle Factor’ will train high-working memory within general short-term memory, (2) ‘Mind’s Eye’ will train low-working memory within general short-term memory, (3) ‘Scene Crasher’ will train short-term memory within general short-term memory, (4) ‘Card Shark’ will train updating within executive function, (5) ‘Mind Bender’ will train shifting within executive function, and (6) ‘Relaxed and Ready’ will train inhibition within executive function. Participants will begin the training protocol on the least challenging level and the program will increase or decrease (i.e., adapt) task difficulty depending on participant progress during training. Participants will complete 20 minutes of CCT, 5 days a week for 12 weeks, totalling 20 hours of CCT.
Intervention code [1] 313119 0
Rehabilitation
Intervention code [2] 314217 0
Prevention
Comparator / control treatment
The same training protocol and Brain HQ exercises will be completed by participants in the non-adaptive CCT group to ensure intervention parameters (i.e., stimuli, length of training) are equal across groups. However, training exercises will be limited to the least challenging level (i.e., non-adaptive) to ensure no therapeutic benefit is experienced during training. It is also important to emphasise that participants recruited into the trial will not experience any disruption or interference to their standardised cochlear implant surgery protocol. Participants that volunteer for the trial will only complete additional computer-based brain training as an additional and potentially therapeutic technique to improve outcomes.
Control group
Active

Outcomes
Primary outcome [1] 308387 0
Change in performance on Letter Number Sequencing (LNS) test score as a measure of high-working memory
Timepoint [1] 308387 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Primary outcome [2] 308388 0
Change in performance on the Paired Associates Learning (PAL) test as a measure of low-working memory
Timepoint [2] 308388 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Primary outcome [3] 308389 0
Change in performance on the Delayed Matching to Sample (DMS) test as a measure of short-term memory
Timepoint [3] 308389 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [1] 354833 0
Change in performance on the N-back task as a measure of updating ability
Timepoint [1] 354833 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [2] 354834 0
Change in performance on the Trail Making Test (Part B-A) as a measure of shifting ability
Timepoint [2] 354834 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [3] 354835 0
Change in performance on the Multitasking Test (MTT) as a measure of inhibition
Timepoint [3] 354835 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [4] 354836 0
Change in pure-tone average (PTA) hearing thresholds across octave frequencies between 0.25 to 4kHz of 20 to 65 dB. Assessed by an Equinox 2.0 clinical audiometer.
Timepoint [4] 354836 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [5] 354837 0
Change in performance on the Consonant Vowel Consonant (CVC) words list as a measure of speech perception
Timepoint [5] 354837 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [6] 354838 0
Change in performance on the City University of New York (CUNY) sentences test as a measure of speech perception
Timepoint [6] 354838 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [7] 354839 0
Change in scores on the Depression, Anxiety, and Stress Scale (DASS-21)
Timepoint [7] 354839 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.
Secondary outcome [8] 354840 0
Change in scores on the Nijmegen Cochlear Implant Questionnaire (NCIQ) as a measure of quality of life
Timepoint [8] 354840 0
Baseline (Week 0) and post-intervention (Week 18). Post-intervention assessments will occur during week 18 of the trial but will be immediately following the 12 week intervention, because there will be a 6 week period between baseline assessments and when participants begin the intervention for when they undergo cochlear implant surgery and recovery.

Eligibility
Key inclusion criteria
To be included in this study participants must meet the following inclusion criteria: (1) 18 years of age or older, (2) met clinical criteria for their first unilateral cochlear implant, (3) demonstrate presence of symmetrical hearing loss, and (4) be a native English speaker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they: (1) demonstrate presence of severe cognitive decline measured by the Hearing Impaired Montreal Cognitive Assessment (HI-MoCA) screening test as a total score equal to or less than 17 out of 30, (2) demonstrate presence of pre-lingual hearing impairment, (3) have previously received a cochlear implant, (4) have previous experience or currently use cognitive training, (5) unable to use or have access to a personal computer connected to the internet and (6) hearing thresholds are indicative of single-sided deafness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Evidence from our recent meta-analysis of cognitive training for adults with hearing loss reported beneficial effects ranging from small to large (Lawrence et al., 2018), with contributing studies including 10 to 67 participants. Using G*Power (Faul, Erdfelder, Lang, & Buchner, 2007), an a-priori power analysis was conducted to determine the required sample size when comparing two intervention groups across three measurement intervals (i.e., pre-intervention, post-intervention, and 3-month follow-up). To detect a medium effect (f 2 = .25) at an alpha of .05 and power of .90, 36 participants will need to be recruited. To account for potential 20% attrition, 44 participants (i.e., 22 per group) will be targeted for recruitment.

SPSS (version 24) will be used to calculate descriptive statistics for demographic data and outcome test results at pre-intervention, post-intervention, and 3-month follow-up assessments. Generalised linear mixed models (GLMMs) will be used to analyse outcome variables. Each GLMM will be assessed for statistically significant Group x Time interaction effects, main effects of Time (per group), and pairwise contrasts. Following a wave of recent criticism drawing attention to the limitations of the frequentist approach (i.e., p values and alpha levels) of statistical analysis, there has been increasing recommendations for researchers to report Bayes factors to support the interpretation of their findings (Quintana & Williams, 2018). Within the frequentist approach, it is most frequently misunderstood that a statistically significant p value (i.e., p = .05) provides evidence in support of an alternative hypothesis. Whereas a statistically significant p value can only provide evidence to disprove the null hypothesis and cannot suggest whether the observed data supports an alternative hypothesis (Quintana & Williams, 2018). Compared to the frequentist approach, however, the Bayesian framework allows researchers to quantify whether changes in their observed data favour the null hypothesis or their alternative hypothesis by considering prior odds (i.e., prior evidence of similar effects). It is therefore important that researchers report Bayes Factors alongside frequentist statistics to provide a more informative interpretation of their findings. From the GLMM results, Bayes Factors will be approximated using the Bayesian Information Criterion (BIC) from each model (i.e., H0 and H1) and reported to provide evidence of whether auditory training combined with adaptive CCT improves study outcomes to a greater extent than auditory training combined with non-adaptive (i.e., placebo) CCT.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301410 0
Other Collaborative groups
Name [1] 301410 0
Ear Science Institute Australia
Country [1] 301410 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Ear Science Institute Australia
Address
1 Salvado Road, Subiaco, WA, 6008
Country
Australia
Secondary sponsor category [1] 301087 0
University
Name [1] 301087 0
The University of Western Australia
Address [1] 301087 0
35 Stirling Highway, Crawley, WA, 6009
Country [1] 301087 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302145 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 302145 0
35 Stirling Hwy, Crawley WA 6009
Ethics committee country [1] 302145 0
Australia
Date submitted for ethics approval [1] 302145 0
18/03/2019
Approval date [1] 302145 0
17/04/2019
Ethics approval number [1] 302145 0
RA/4/20/5287

Summary
Brief summary
Cochlear implant surgery is used to treat moderately-severe to profound hearing loss, but there are currently no treatments for cognitive impairment associated with hearing loss. The current clinical trial will examine and compare different types of computer-based brain training activities to determine which type of training will improve memory and thinking skills, hearing abilities, mood, and quality of life in adults with cochlear implants. We hypothesise that cochlear implant recipients will experience significant improvement in memory and thinking skills, hearing abilities, mood, and quality of life in response to auditory training combined with cognitive training. Considering that dementia is now the second leading cause of death in Australia and mid-life hearing loss may predict the development of dementia in later-life, findings from this study have the potential to inform the broader community of steps they can take to potentially limit and prevent the onset of dementia associated with their hearing loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89274 0
Dr Blake Lawrence
Address 89274 0
Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008
Country 89274 0
Australia
Phone 89274 0
+61 415621061
Fax 89274 0
Email 89274 0
[email protected]
Contact person for public queries
Name 89275 0
Dr Blake Lawrence
Address 89275 0
Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008
Country 89275 0
Australia
Phone 89275 0
+61 415621061
Fax 89275 0
Email 89275 0
[email protected]
Contact person for scientific queries
Name 89276 0
Dr Blake Lawrence
Address 89276 0
Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008
Country 89276 0
Australia
Phone 89276 0
+61 415621061
Fax 89276 0
Email 89276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To ensure anonymity of sensitive health and demographic data provided by participants, no individual participant data will be made available from this trial.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAuditory-cognitive training for adult cochlear implant recipients: a study protocol for a randomised controlled trial.2021https://dx.doi.org/10.1186/s13063-021-05714-7
N.B. These documents automatically identified may not have been verified by the study sponsor.