Chronic StressNCT07217951
Assessing the Feasibility of Multi-modal Biosensing for Monitoring Mobility and Cognition in Older Adults
An observational study of Chronic Stress and Systemic Inflammation, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress, Systemic Inflammation, Mobility and Independence
- What is being tested?
- Eutectogel Sensors and Microneedle Patches
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adults aged 65 and older.
Who may be able to join
- Aged 65 or older
- Expressed willingness to participate.
- Able to give written informed consent
- Able to operate a smartphone and complete surveys
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emilie Buisson, MS contact
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
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.
Read the 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.
- Being tested
- Eutectogel Sensors and Microneedle Patches
- Keywords
- wearable sensors, older adults, aging, mobility, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eutectogel Sensors and Microneedle PatchesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Adults aged 65 or older Receives: Device: Eutectogel Sensors and Microneedle Patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to end of study period at 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study startDec 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sameer Sonkusale, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217951
- Sponsor's protocol ID
- R01AG091766
- Other IDs
- R01AG091766
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15817019Dongiovanni 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.
PubMed 37386003Wu 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.
PubMed 30008593Gupta 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.
PubMed 29391704Iijima H, Shimoura K, Eguchi R, Aoyama T, Takahashi M. Concurrent validity and measurement error of stair climb test in people with pre-radiographic to mild knee osteoarthritis. Gait Posture. 2019 Feb;68:335-339. doi: 10.1016/j.gaitpost.2018.12.014. Epub 2018 Dec 10.
PubMed 30576977Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Gelatin Food additive and GRAS regulations. U.S. Food and Drug Administration; 2025.
184.1724 Sodium Alginate. Code of Federal Regulations Title 21.
CELLULOSE, MICROCRYSTALLINE. U.S. Food and Drug Administration; 2025
Master H, Coleman G, Dobson F, Bennell K, Hinman RS, Jakiela JT, White DK. A Narrative Review on Measurement Properties of Fixed-distance Walk Tests Up to 40 Meters for Adults With Knee Osteoarthritis. J Rheumatol. 2021 May;48(5):638-647. doi: 10.3899/jrheum.200771. Epub 2020 Oct 15.
PubMed 33060316182.1320 Glycerin. Code of Federal Regulations Title 21, Environmental Protection Agency; 2025
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Multi-modal Biosensing for Monitoring Mobility and Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT07217951
- Acronym / sponsor ID
- R01AG091766
- Keywords
- wearable sensors, older adults, aging, mobility, inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults | – | Device: Eutectogel Sensors and Microneedle PatchesAdults aged 65 or older |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults aged 65 and older.
Key inclusion criteria (4 listed)
- Aged 65 or older
- Expressed willingness to participate.
- Able to give written informed consent
- Able to operate a smartphone and complete surveys
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eutectogel Sensors and Microneedle PatchesEutectogel 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. | Device | Older adults |
Primary outcome
Subtle biomechanical signals and interstitial fluid with key biomarkers.
Time frame: From enrollment to end of study period at 8 days.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 37386003Dongiovanni 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.
- BackgroundWu 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,
- BackgroundCheng 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.
- BackgroundCheng K, Aeron S, Hughes MC, Miller EL. Dynamical Wasserstein barycenters for time-series modeling. Advances in Neural Information Processing Systems. 2021;34:27991-28003
- BackgroundZhang 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.
- Background: PubMed 30008593Bhattarai 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.
- Background: PubMed 29391704Gupta 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.
- Background: PubMed 30576977Iijima H, Shimoura K, Eguchi R, Aoyama T, Takahashi M. Concurrent validity and measurement error of stair climb test in people with pre-radiographic to mild knee osteoarthritis. Gait Posture. 2019 Feb;68:335-339. doi: 10.1016/j.gaitpost.2018.12.014. Epub 2018 Dec 10.
- Background: PubMed 10380242Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
- BackgroundGelatin Food additive and GRAS regulations. U.S. Food and Drug Administration; 2025.
- Background184.1724 Sodium Alginate. Code of Federal Regulations Title 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie Buisson, MS contact
Sameer Sonkusale, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stress and Systemic Inflammation, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyla Shea, PhD (16175563370, Kyla.Shea@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subtle biomechanical signals and interstitial fluid with key biomarkers. (time frame: From enrollment to end of study period at 8 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07217951, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.