Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users

NCT01732887 | Terminated

• 1 other identifier: NCIL-CI-CF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we are testing computer-based brain fitness exercises. The games are designed to improve people's cognitive abilities brain functions, like memory, concentration, and ability to do two things at once. We are testing whether this cognitive training brain exercises will improve understanding of spoken sentences speech comprehension in people who use cochlear implant and/or hearing aids. We predict that cognitive training will improve speech comprehension in cochlear implant and/or hearing aid users.

Conditions

Deafness; Speech Intelligibility

Keywords

cochlear implants; speech comprehension; cognitive training; cognitive fitness; intervention; memory; attention; rehabilitation

Outcome Measures

Primary Outcomes (1)

• AzBio Sentence test - change in score from baseline to post-training

  Sentences are played along with masking noise (multi-talker babble). Participants must repeat each sentence as they heard it. Accuracy in repeating the sentences is the outcome measure.

  Baseline, Weeks 10, 20 and 30

Secondary Outcomes (4)

• Change from Baseline in CANTABeclipse for clinical trials

  Baseline, Weeks 10, 20 and 30

• Change from Baseline in Speech Spatial Qualities questionnaire

  Baseline, Weeks 10, 20 and 30

• Change from Baseline in CogniFit NeuroPsychological Assessment

  Baseline, Weeks 10, 20 and 30

• Adherence record

  Upto 30 weeks

Study Arms (2)

Immediate cognitive fitness training

OTHER

After the initial baseline evaluation, the immediate treatment group participants will receive individualized multi-domain cognitive training and standard of care. Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval. After 10 weeks of cognitive fitness training, participants in this group will switch to a 20 week "no intervention" period where they receive only standard of care treatment.

Other: Cognitive fitness training

Delayed cognitive fitness training

OTHER

After the initial baseline evaluation, the delayed cognitive fitness training group participants will receive only standard of care for 10 weeks ("no intervention" period). Starting in week 11, participants in this arm will receive individualized multi-domain cognitive training and standard of care. Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval. After 10 weeks of cognitive fitness training, participants will go for another 10 weeks with only standard of care treatment.

Other: Cognitive fitness training

Interventions

Cognitive fitness training OTHER

Computer-based training of basic cognitive functions. It has activities under two headings, 1. General training applications 2. Memory training applications Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval.

Delayed cognitive fitness training; Immediate cognitive fitness training

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult cochlear implant users, and/or people with moderate/severe hearing loss using bilateral hearing aids, aged 19 or above
• Access to an internet-connect device that supports flash, and basic computer skills
• Medically stable patients

You may not qualify if:

• Patients with epilepsy, severe visual and cognitive difficulties, chronic fatigue syndrome, and serious co-morbid conditions which could be exacerbated by the computer training games will be excluded for safety reasons.
• Patients who are unlikely to adhere to the intervention due to dementia, Parkinson's disease, Parkinson-plus syndrome, movement disorders or disability that would impair the person's ability to perform the training (e.g., problems with attention, alertness, or learning disorders)
• Participants who cannot speak English (since study materials are only in English), or unable to give consent.

Sponsors & Collaborators

• Aaron Newman: lead
• University of Oslo: collaborator
• CogniFit Limited: collaborator

Study Sites (1)

NeuroCognitive Imaging Lab, Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Related Links

• NeuroCognitive Imaging Lab (NCIL) is a service of Department of Psychology at Dalhousie University, Canada. Participants visit the NCIL to complete a cognitive and hearing assessment. However, they perform the training tasks from their own homes.
• The Department of Community Medicine is primary affiliation of the Sub-Investigator, Dr. Amit Bansal. He is pursuing M.Phil International Community Health at the University of Oslo, Norway under supervision of Drs. Gradmann, Lian and Newman.
• The clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada

MeSH Terms

Conditions

Deafness; Speech Intelligibility

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Speech; Verbal Behavior; Communication; Behavior

Study Officials

• Aaron Newman, PhD

  Dalhousie University, Canada

  PRINCIPAL INVESTIGATOR

• Christoph Gradmann

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Affiliated Scientist

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 26, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

CA (1)