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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Oslo
CogniFit Limited
Information provided by (Responsible Party):
Aaron Newman, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01732887
First received: November 14, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Deafness
Speech Intelligibility
Other: Cognitive fitness training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Short-term Effects of Home-based Computerized Multi-domain Cognitive Training in Adult Cochlear Implant and/or Hearing Aid Users: A Prospective Randomized Intervention Study

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • AzBio Sentence test - change in score from baseline to post-training [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in CANTABeclipse for clinical trials [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]
    It is a method of assessing the brain-functions of a person using computerized non-linguistic tests by touch screen technology making it rapid and safe. It has been widely used globally to assess brain-functions in more than 100 disorders. More than 700 articles have been published using CANTABeclipse by over 500 academic institutions or industry researchers in 60 different countries. Tasks are performed by touch screen technology. It assesses brain-functions such as planning, problem solving, working memory etc.

  • Change from Baseline in Speech Spatial Qualities questionnaire [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]
    The Spatial Speech Qualities of Hearing scale questionnaire (SSQ; Gatehouse & Noble, 2004) is used to assess the self reported hearing disabilities across several domains such as hearing speech in challenging contexts and to the directional, distance and movement components of spatial hearing.

  • Change from Baseline in CogniFit NeuroPsychological Assessment [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]
    The CogniFit Neuropsychological assessment is a multi domain cognitive task. It measures 18 cognitive abilities such as visuospatial working memory, visuospatial learning, focused attention, updating, monitoring etc. (Haimov et al., 2008; Peretz et al., 2011b; Shatil et al., 2010; Verghese et al., 2010)

  • Adherence record [ Time Frame: Upto 30 weeks ] [ Designated as safety issue: No ]
    Access usage data from CogniFit website will be recorded. Recording includes time spent on each session (start and end time), number of games played during each session


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immediate cognitive fitness training
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

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
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

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.


Detailed Description:

Aural rehabilitation is a life long process in spite of advanced innovative implant technology. Existing standard therapy is inadequate for some people, because even after years of surgery many implant users does not obtain significant benefits, like improved understanding of spoken sentences. In many cases it seems that the speech comprehension deficits are linked to particular cognitive functions in cochlear implant users, including memory and attention. In this study we will test whether a computer-based set of "cognitive fitness" or "brain training" games designed to improve memory and attention will help cochlear implant and hearing aid users to understand speech better.

Cochlear implant and hearing aid users will complete 10 weeks of computer-based cognitive training on their home computers. Half of participants will do this training immediately after being enrolled in the study; the other half will receive the training beginning 10 weeks after they are enrolled. Speech comprehension and cognitive abilities will be assessed at baseline, 10, 20 and 30 weeks in all participants.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732887

Locations
Canada, Nova Scotia
NeuroCognitive Imaging Lab, Dalhousie University
Halifax, Nova Scotia, Canada, B3H 4R2
Sponsors and Collaborators
Aaron Newman
University of Oslo
CogniFit Limited
Investigators
Principal Investigator: Aaron Newman, PhD Dalhousie University, Canada
Principal Investigator: Christoph Gradmann University of Oslo, Norway
  More Information

Additional Information:
No publications provided

Responsible Party: Aaron Newman, Affiliated Scientist, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01732887     History of Changes
Other Study ID Numbers: NCIL-CI-CF
Study First Received: November 14, 2012
Last Updated: February 26, 2014
Health Authority: Canada: Ethics Review Committee
Norway: Ethics Committee

Keywords provided by Capital District Health Authority, Canada:
cochlear implants
speech comprehension
cognitive training
cognitive fitness
intervention
memory
attention
rehabilitation

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014