About this trial
The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
comfortably ambulatory healthy physical condition
normal or corrected to normal visual
auditory acuity
fluency in spoken English
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
MediTrain
DeviceParticipants will engage with a digital meditation app for 30m/day for 6wks. MediTrain 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.
wrist worn multi-sensor watches
DeviceStress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.
Sleep monitor
DeviceSleep Profiler devices are FDA-cleared reduced-montage EEG recording devices that will be used in accordance with its FDA clearance. They are completely non-invasive and are designed to be comfortable enough to wear all night without interfering with normal sleep. These devices enable quality sleep recordings in the comfort of people's homes, rather than required an overnight stay at a sleep lab at UCSF.
Treatment groups
Trial outcomes
Primary outcomes
Mean change on the Continuous Performance Task (CPT) over time
Mean change in sleep quality
Mean change in sleep quality (i.e., total sleep time / time in bed, therefore this measure incorporates latency to sleep onset, total sleep time, wake after sleep onset and early morning waking, with higher numbers associated with better sleep) over time \[Time Frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants\]
Mean change in measures of stress reactivity over time
Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task
Secondary outcomes
Mean change in Telomere length (quantified in peripheral blood cells) over time
200 mL of blood will be collected from each participant before and after the intervention. Blood will be centrifuged for whole blood cell acquisition and stored at -80 °C for subsequent batch testing. Telomere length (T/S ratio) will be quantified in peripheral blood mononuclear cells.
Mean change on a distracted attention task over time
Mean performance on a distracted attention task will be compared pre and post intervention. Divided attention performance will be assessed using the Filter Task that places simultaneous demands on perceptual discrimination abilities and distraction filtering.
Mean change in Frontal Theta Power over time
Based on previous studies of meditation training and our preliminary data, we predict that MediTrain will lead to significantly enhanced midline frontal theta power during the TOVA in MCI as compared to OA. Beyond most prior studies, by collecting structural MRI data, we will be able to source-localize any observed changes in midline frontal theta.
Mean change in resting state networks over time
We also expect MediTrain will augment intrinsic Default Mode Network (DMN) connectivity, both functionally (measured with resting fMRI111,112) and structurally (measured with DTI-based connectomes). This is hypothesized based on the known association between the DMN,
Other outcomes
Mean 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, meditation, and frontal theta power.
Mean change in continuous recordings of sleep metrics.
We will assess time spent in NonREM stages 1 (N1), 2 (N2) and 3 (N3) sleep and REM sleep (RS), latency to sleep onset (SOL), and wake after sleep onset (WASO). We will also assess delta power during sleep stages and wake; and overall sleep maintenance (SM) and sleep efficiency (SE). Diminished time spent in SOL and WASO, increased time N2, N3 and REM sleep, increased delta during NonREM sleep are each signs of improved sleep. Increases in SM and SE indicated improved, more stable sleep patterns
mean change in Change in Mnemonic Discrimination over time
Mnemonic discrimination task tests recognition memory for common objects, as reported in scores on a scale of the Lure Discrimination Index ranging from 0.00 to 1.00 where higher values show better performance.
mean change in Task-based Cortical Functional Connectivity
functional MRI data associated With Training-induced Changes in Mnemonic Discrimination will be analyzed in terms of beta-series correlations between co-active cortical regions of interest and compared between treatment arms and timepoints.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute on Aging (NIA)
Collaborator