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A trial of computerised brain training to improve cognitive function in adults with cochlear implants

A randomised controlled trial of auditory-cognitive training for cognition in adults with cochlear implants

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000609156
Enrollment
44
Registered
2019-04-23
Start date
2021-06-01
Completion date
2022-06-01
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Ear Science Institute Australia
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026