Enhancing Attention and Wellbeing Using Digital Therapeutics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-99
SponsorUniversity of California, San Francisco
About this trial
The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
60+ years old (adult)
English language fluency
owning a smartphone or tablet
Disqualifiers
Under 60 years old (minor)
Trial design
Design model
Parallel
Treatments tested in this trial
MediTrain
DeviceMediTrain is a tablet-based, meditation-inspired, cognitive training game aimed at improving self-regulation of internal attention and distractions. It was developed in collaboration with meditation thought-leader Jack Kornfield, and Zynga, a world-class video game company. It was created to make benefits of concentrative meditation more easily accessible to anyone, including complete novices. This is achieved by creating a game that yields quantifiable and attainable goals, provides feedback, and includes an adaptive algorithm to gradually increase difficulty as users improve.
Worder
DeviceWorder was designed to enhance visual motor and visual spatial skills in individuals of all ages and cognitive abilities. Visual processing is required for all cognitive abilities that involve vision including attention, working memory, and task management. Worder's goal is to improve cognitive function more broadly by developing this critical skill underlying multiple abilities.
Treatment groups
4,000 Participants
are divided into 5 treatment groupsGroup A: MediTrain 30m/day for 6wksExperimental treatment 1 intervention
Group B: MediTrain 15m/day for 6wksExperimental treatment 1 intervention
Group C: MediTrain 30m/day for 3wksExperimental treatment 1 intervention
Group D: MediTrain 15m/day for 3wksExperimental treatment 1 intervention
Group E: Active Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change on the Mobile Continuous Performance Task (CPT) over time
The CPT is a 23-minute task, where participants are instructed to respond to target stimuli (squares at the top of the screen) and withhold responses to non-target stimuli (squares at the bottom of the screen). Performance will be quantified as: (1) mean reaction times, (2) standard deviation of reaction times (RTV), and (3) d-prime (comparing correct target detections or 'hits' to incorrect non-target detections or 'false alarms').
Time frame
baseline, immediate follow-up, and at a 6 month follow-upSecondary outcomes
1
Change on the Adaptive Cognitive Evaluation (ACE) over time
The ACE is a mobile cognitive assessment tool, which includes a battery of cognitive control tests for rapid tests of cognition. The sub-tests (or 'modules') in ACE are adapted from standardized tasks to rapidly assess various aspects of cognition, including attention, memory, and multitasking. We will assess response time, accuracy, and response time variability in each case, with faster/more accurate/less variable performance being indicative of improved cognitive control.
Time frame
baseline, immediate follow-up, and at a 6 month follow-upOther outcomes
1
Mean Change on Everyday Cognition Scale (ECog)
• Mean Change on Everyday Cognition Scale (ECog) The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition.
Time frame
baseline, immediate follow-up, and at a 6 month follow-up2
Mean Change on Pittsburgh Sleep Quality Index (sleep)
• Pittsburgh Sleep Quality Index (sleep) The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Overall scores range from 0 to 21, with lower scores representing healthier sleep quality. We will report change in means over time.
Time frame
baseline, immediate follow-up, and at a 6 month follow-up3
Mean Change on Framingham Cardiovascular Risk Score
• Framingham Cardiovascular Risk Score The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. We will use the BMI version of the score. Scores range from 0-100% risk of cardiac event or death. We will report change in means over time.
Time frame
baseline, immediate follow-up, and at a 6 month follow-up4
Mean Change on SF-36 (overall health)
• SF-36 (overall health) The general health and well-being (SF-36) score assesses participant health. The SF-36 score ranges from 0 to 100. The higher the overall score is on this measure, the better one is performing with respect to their health and well-being.
Time frame
baseline, immediate follow-up, and at a 6 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov