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

Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: 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 train CONDITION: Ear ‐ Deafness Mental Health ‐ Studies of normal psychology, cognitive function and behaviour Moderately‐severe to profound hearing loss;Cognitive function;Mood;Quality of life; ; Moderately‐severe to profound hearing loss ; Cognitive function ; Mood ; Quality of life 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. PRIMARY OUTCOME: Change in performance on Letter Number Sequencing (LNS) test score as a measure of high‐working memory[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.] Change in performance on the Delayed Matching to Sample (DMS) test as a measure of short‐term memory[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.] Change in performance on the Paired Associates Learning (PAL) test as a measure of low‐working memory[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: Change in performance on the City University of New York (CUNY) sentences test as a measure of speech perception[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.] Change in performance on the Consonant Vowel Consonant (CVC) words list as a measure of speech perception[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.] Change in performance on the Multitasking Test (MTT) as a measure of inhibition[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.] Change in performance on the N‐back task as a measure of updating ability[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.] Change in performance on the Trail Making Test (Part B‐A) as a measure of shifting ability[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.] 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.[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.] Change in scores on the Depression, Anxiety, and Stress Scale (DASS‐21)[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.] Change in scores on the Nijmegen Cochlear Implant Questionnaire (NCIQ) as a measure of quality of life[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.]
Epistemonikos ID: 93dd30f80c07c5193259697cc2b216056b99e647
First added on: Aug 24, 2024