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

NCT ID: NCT07217951

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-09-30

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.

Detailed Description

Devices capable of measuring, interpreting, and providing guidance based on a range of biosignals have significantly broadened the access to health information. Nevertheless, the majority of these platforms are designed for a demographic already proficient in technology, thereby excluding older adults, a group facing unique health challenges and often experiencing technological apprehension. To address this disparity, this study aims to demonstrate the feasibility of employing a wearable eutectogel-sensor patch system to monitor and analyze posture, movement, heart rate, and respiration of older adults within their natural living environments. Furthermore, investigators seek to develop algorithms that correlate these real-time data streams with physical and cognitive performance outcomes. Concurrently, they will investigate the feasibility of employing hydrogel microneedle patches for the passive collection of interstitial fluid (ISF) to measure key biomarkers associated with stress and inflammation, specifically cortisol, dopamine, and C-reactive protein (CRP). These biomarkers serve as critical indicators of physiological stress, mood regulation, and systemic inflammation, which are closely associated with cognitive decline, frailty, and diminished quality of life in the aging population. Eutectogel sensor patches are flexible, breathable, inconspicuous, and designed for long-term wear. They can be positioned strategically to provide direct, continuous, real-time monitoring of posture, motion, heart rate, and respiration. We now propose to determine the feasibility of using a eutectogel sensor patch system to continuously collect posture, motion, heart rate, and respiration data in free-living older adults. Investigators will secondly assess the feasibility of measuring dopamine, cortisol, and CRP from ISF collected with a microneedle patch and correlate them with the same analytes measured in saliva. These analytes were selected due to their relevance in detecting chronic stress and systemic inflammation-conditions that are highly prevalent and often underdiagnosed in the aging population. The research objectives are significant because they aim to bridge the technological and demographic gap through a combined sensing system that enables seamless and meaningful health monitoring in real-world settings.

Conditions

Chronic Stress; Systemic Inflammation; Mobility and Independence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Older adults

Adults aged 65 or older

Eutectogel Sensors and Microneedle Patches

Intervention Type: 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.

Interventions

Eutectogel Sensors and Microneedle Patches

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 65 or older

2. Expressed willingness to participate.

3. Able to give written informed consent

4. Able to operate a smartphone and complete surveys

Exclusion Criteria

1. Reliance on assistive walking devices

2. Inability to operate a smartphone

3. Unable to complete surveys

4. Unable to give written informed consent

5. Younger than 65 years old

6. Known skin allergies to kinesiology tape (KT tape)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sameer Sonkusale, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Kyla Shea, PhD

Role: CONTACT

Kyla.Shea@tufts.edu

16175563370

Emilie Buisson, MS

Role: CONTACT

emilie.buisson@tufts.edu

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Other Identifiers

R01AG091766

Identifier Type: NIH

Identifier Source: secondary_id

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R01AG091766

Identifier Type: NIH

Identifier Source: org_study_id

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