Assessing the Feasibility of Multi-modal Biosensing for Monitoring Mobility and Cognition in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eutectogel Sensors and Microneedle Patches.
- Who it may be relevant to
- Registry conditions: Chronic Stress, Systemic Inflammation, Mobility and Independence. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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
Primary outcome measures
- Subtle biomechanical signals and interstitial fluid with key biomarkers. [Time frame: From enrollment to end of study period at 8 days.]
Eligibility criteria
Inclusion criteria
- Aged 65 or older
- Expressed willingness to participate.
- Able to give written informed consent
- Able to operate a smartphone and complete surveys
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Jean Mayer USDA Human Nutrition Research Center on Aging — Boston
Publications
- Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. PMID 15817019
- Dongiovanni P, Meroni M, Casati S, Goldoni R, Thomaz DV, Kehr NS, Galimberti D, Del Fabbro M, Tartaglia GM. Salivary biomarkers: novel noninvasive tools to diagnose chronic inflammation. Int J Oral Sci. 2023 Jun 29;15(1):27. doi: 10.1038/s41368-023-00231-6. PMID 37386003
- Wu Z, Qiao Z, Chen S, et al. Interstitial fluid-based wearable biosensors for minimally invasive healthcare and biomedical applications. Communications Materials. 2024;5(1):33. 10.1038/s43246-024-00468-6,
- Cheng KC, Aeron S, Hughes MC, Miller EL. Nonparametric and Regularized Dynamical Wasserstein Barycenters for Sequential Observations. IEEE Transactions on Signal Processing. 2022;71:3164-3178.
- Cheng K, Aeron S, Hughes MC, Miller EL. Dynamical Wasserstein barycenters for time-series modeling. Advances in Neural Information Processing Systems. 2021;34:27991-28003
- Zhang H, Miller EL, Abriola LM. Manifold regression for subsurface contaminant characterization based on sparse concentration data. Paper presented at: 2014 IEEE Geoscience and Remote Sensing Symposium; 13-18 July 2014, 2014.
- Bhattarai KR, Kim HR, Chae HJ. Compliance with Saliva Collection Protocol in Healthy Volunteers: Strategies for Managing Risk and Errors. Int J Med Sci. 2018 May 22;15(8):823-831. doi: 10.7150/ijms.25146. eCollection 2018. PMID 30008593
- Gupta S, Nayak MT, Sunitha JD, Dawar G, Sinha N, Rallan NS. Correlation of salivary glucose level with blood glucose level in diabetes mellitus. J Oral Maxillofac Pathol. 2017 Sep-Dec;21(3):334-339. doi: 10.4103/jomfp.JOMFP_222_15. PMID 29391704
Identifiers
NCT: NCT07217951 · R01AG091766 · R01AG091766