Assessing the Feasibility of Multi-modal Biosensing for Monitoring Mobility and Cognition in Older Adults

NCT07217951 | Not Yet Recruiting

• 1 other identifier: R01AG091766
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stress; Systemic Inflammation; Mobility and Independence

Keywords

wearable sensors; older adults; aging; mobility; inflammation

Outcome Measures

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

  From enrollment to end of study period at 8 days.

Study Arms (1)

Older adults

Adults aged 65 or older

Device: Eutectogel Sensors and Microneedle Patches

Interventions

Eutectogel Sensors and Microneedle Patches DEVICE

Eutectogel 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.

Older adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults aged 65 and older.

You may qualify if:

• Aged 65 or older
• Expressed willingness to participate.
• Able to give written informed consent
• Able to operate a smartphone and complete surveys

You may not qualify if:

• Reliance on assistive walking devices
• Inability to operate a smartphone
• Unable to complete surveys
• Unable to give written informed consent
• Younger than 65 years old
• Known skin allergies to kinesiology tape (KT tape)

Sponsors & Collaborators

• Tufts University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameer Sonkusale, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyla Shea, PhD

CONTACT

16175563370; Kyla.Shea@tufts.edu

Emilie Buisson, MS

CONTACT

emilie.buisson@tufts.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)