Studying the Effects of Digital Interventions on Cognition, Wellbeing, Stress, and Sleep in Older Adults
- Conditions
- MCIAging
- Interventions
- Device: MediTrainDevice: wrist worn multi-sensor watchesDevice: Sleep monitor
- Registration Number
- NCT06633978
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MediTrain Sleep monitor - MediTrain MediTrain - MediTrain wrist worn multi-sensor watches -
- Primary Outcome Measures
Name Time Method Mean change on the Continuous Performance Task (CPT) over time baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants Mean change in sleep quality baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants 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 baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task
- Secondary Outcome Measures
Name Time Method Mean change in Telomere length (quantified in peripheral blood cells) over time baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants 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 baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants 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 baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants 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 baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants 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,
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States