Assessing the Feasibility of Multi-modal Biosensing for Monitoring Mobility and Cognition in Older Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorTufts University
About this trial
Current health devices often overlook older users, who may face both health challenges and technology barriers. We are investigating the feasibility of wearable sensors to track posture, heart rate, and breathing, alongside a microneedle patch that collect body fluids to measure stress and inflammation markers. By combining this data, we aim to create an easy to use system that supports personalized, at home health monitoring for older adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 65 or older
Expressed willingness to participate.
Able to give written informed consent
Able to operate a smartphone and complete surveys
Disqualifiers
Reliance on assistive walking devices
Inability to operate a smartphone
Unable to complete surveys
Unable to give written informed consent
Trial population
Older adults aged 65 and older.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Eutectogel Sensors and Microneedle Patches
DeviceEutectogel Sensors: While the exact eutectogel formulation in this study has not been previously tested in humans, similar eutectogel-based materials have been employed in wearable biosensing devices with human participants. These systems are typically composed of biocompatible matrices such as gelatin or polyacrylamide combined with deep eutectic solvents (DES) to improve ionic conductivity and flexibility. Microneedle Patches: The microneedle patch in this study is composed of poly(acrylic acid)/gelatin methacryloyl (PAA/GelMA), gelatin/oxidized pectin (Gelatin/OxP), and methacrylated hyaluronic acid/maleic anhydride (MeHA/MA). Although the integrated use of these specific compositions has not yet been evaluated in humans, the materials themselves, as well as similar microneedle architectures, have been thoroughly investigated in vivo and even in clinical trials.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Older adults1 intervention
Trial outcomes
Primary outcomes
1
Subtle biomechanical signals and interstitial fluid with key biomarkers.
We propose the use of eutectogel-based strain sensors as a soft, conformable platform for capturing subtle biomechanical signals, including posture shifts, respiratory motion, and joint movements. These gels offer unique advantages in comfort and stretchability that make them ideal for long-term use by older adults. Complementing this, we integrate hydrogel-based microneedle patches for the continuous and minimally invasive collection of interstitial fluid to measure key biomarkers: cortisol and dopamine (using the PAA/GelMA microneedle-dPAD system) and C-reactive protein (via the Gelatin/OxP microneedle µPAD platform). These biomarkers are critically relevant to monitoring stress, inflammation, and mental health-all major contributors to declining independence in aging populations. By applying machine learning methods to passively interpret this multimodal dataset, our approach addresses the unmet need for integrated, unobtrusive health monitoring systems tailored to the aging popula
Time frame
From enrollment to end of study period at 8 days.Sponsors and contacts
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Tufts University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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