NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST)

NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST)

The NeuroFinance Human Stress Trial (NFHST-2026-001) is a decentralized observational clinical study designed to evaluate how financial market volatility, economic uncertainty, digital media exposure, and information-driven stress environments affect human physiologic and behavioral health. Participants will undergo remote monitoring using wearable biosensors, cardiovascular telemetry devices, sleep tracking systems, heart rate variability monitoring, and behavioral analytics platforms. The study will use artificial intelligence and machine learning systems to analyze relationships between external financial and informational events and biologic stress responses, including autonomic nervous system activity, sleep disruption, cardiovascular strain, emotional resilience, and inflammatory signaling. The goal of the study is to develop predictive digital biomarkers and AI-assisted forecasting systems capable of identifying stress-related physiologic deterioration before clinical manifestation.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurobehavioral Manifestations; Occupational Stress; Insomnia; Anxiety; Sleep Disturbance; Emotional Stress; Burnout Syndrome; Heart Rate Variability; Financial Stress; Psychological Stress; Behavioral Health; Cognitive Fatigue; Autonomic Nervous System Dysfunction
• Intervention / Treatment: Device: Wearable Physiologic Monitoring Platform

Detailed Description

The NeuroFinance Human Stress Trial (NFHST-2026-001) is a prospective, decentralized observational study designed to evaluate physiologic and behavioral responses associated with exposure to financial market volatility, economic uncertainty, and digitally mediated informational stress environments.

Participants will undergo remote monitoring using commercially available wearable biosensor technologies and digital health platforms. Data collection may include continuous or intermittent monitoring of:

Heart rate variability (HRV) Resting heart rate Sleep duration and sleep efficiency Blood pressure measurements Physical activity metrics Galvanic skin response Voice-based behavioral analytics Optional electrocardiographic monitoring

Environmental and informational exposure datasets may include:

Financial market volatility indices News sentiment datasets Social media exposure metrics Economic uncertainty indicators Behavioral interaction telemetry

Artificial intelligence and machine learning systems may be used for exploratory correlation analyses between physiologic biomarkers and external informational stressors.

No investigational drug or invasive intervention will be administered as part of this observational study.

Optional biologic sampling may include saliva-based inflammatory biomarker collection and participant-reported psychometric assessments.

Primary analyses will evaluate longitudinal changes in physiologic stress-related biomarkers during periods of elevated informational or financial stress exposure.

Secondary analyses will evaluate associations between physiologic variability, behavioral adaptation metrics, sleep disruption, and cognitive performance measures.

The study is intended to support development of digital biomarker methodologies and decentralized monitoring frameworks for stress-related physiologic research.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Gavin C Solomon, Investigator; Phone Number: 15167685264; Email: gavin@truwayhealth.com
• Study Contact Backup: Name: Dr. Alicia Levin, M.D.; Phone Number: 1-833-TRUWAY-1; Email: irb@truwayhealth.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Truway Health, Inc.
      • Contact: Gavin C Solomon, CEO; Phone Number: 5167685264; Email: gavin@truwayhealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult participants exposed to varying levels of financial market activity, economic stress environments, occupational stress, and digital media exposure. Participants may include retail investors, financial professionals, active traders, technology workers, digitally connected individuals, and members of the general population. The study is designed to evaluate physiologic, behavioral, cardiovascular, autonomic nervous system, and sleep-related responses to financial and informational stress environments using wearable biosensors, digital health technologies, and artificial intelligence-assisted analytics platforms.

Description

Inclusion Criteria:

• Adults age 18 years and older.
• Ability to provide informed consent.
• Willingness and ability to comply with study procedures and remote monitoring requirements.
• Access to a compatible smartphone, tablet, or internet-connected device for decentralized study participation.
• Willingness to utilize wearable physiologic monitoring technologies during the study period.
• Participants with varying degrees of financial market exposure, occupational stress exposure, or digital media exposure are eligible.
• Healthy volunteers and participants with self-reported stress-related symptoms may be enrolled.
• Ability to read and understand English-language consent and study materials.

Exclusion Criteria:

• Individuals unable or unwilling to provide informed consent.
• Individuals unable to comply with remote monitoring procedures or wearable device usage requirements.
• Active medical or psychiatric instability that, in the opinion of study investigators, may interfere with study participation or data integrity.
• Current incarceration or institutionalization limiting voluntary participation.
• Participation in another interventional clinical trial that may substantially interfere with physiologic monitoring outcomes.
• Any condition that would significantly impair safe study participation as determined by the study investigators.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retail Investors / Active Traders Cohort; Participants actively engaged in retail equity, options, futures, cryptocurrency, or other financial trading activities who are exposed to frequent market volatility and information-driven financial stress environments.	Device: Wearable Physiologic Monitoring Platform; Commercially available wearable physiologic monitoring devices and digital health technologies will be used to collect continuous or intermittent biometric, cardiovascular, autonomic nervous system, behavioral, and sleep-related data during exposure to financial market volatility, economic uncertainty, and information-driven stress environments. Monitoring technologies may include: wearable ECG devices, heart rate variability (HRV) monitors, blood pressure monitoring systems, sleep tracking devices, galvanic skin response sensors, activity monitoring wearables, voice analysis systems, and optional EEG-enabled wearable technologies. Data generated from these systems will be integrated with artificial intelligence and machine learning-based analytics platforms for evaluation of physiologic stress responses and digital biomarker forecasting.
Financial Professionals Cohort; Participants employed in financial services, institutional trading, investment banking, hedge funds, private equity, fintech, wealth management, or related high-stress financial occupations.	Device: Wearable Physiologic Monitoring Platform; Commercially available wearable physiologic monitoring devices and digital health technologies will be used to collect continuous or intermittent biometric, cardiovascular, autonomic nervous system, behavioral, and sleep-related data during exposure to financial market volatility, economic uncertainty, and information-driven stress environments. Monitoring technologies may include: wearable ECG devices, heart rate variability (HRV) monitors, blood pressure monitoring systems, sleep tracking devices, galvanic skin response sensors, activity monitoring wearables, voice analysis systems, and optional EEG-enabled wearable technologies. Data generated from these systems will be integrated with artificial intelligence and machine learning-based analytics platforms for evaluation of physiologic stress responses and digital biomarker forecasting.
General Population Control Cohort; Participants from the general population with varying levels of financial market exposure serving as a comparative baseline cohort for physiologic and behavioral stress-response analysis.	Device: Wearable Physiologic Monitoring Platform; Commercially available wearable physiologic monitoring devices and digital health technologies will be used to collect continuous or intermittent biometric, cardiovascular, autonomic nervous system, behavioral, and sleep-related data during exposure to financial market volatility, economic uncertainty, and information-driven stress environments. Monitoring technologies may include: wearable ECG devices, heart rate variability (HRV) monitors, blood pressure monitoring systems, sleep tracking devices, galvanic skin response sensors, activity monitoring wearables, voice analysis systems, and optional EEG-enabled wearable technologies. Data generated from these systems will be integrated with artificial intelligence and machine learning-based analytics platforms for evaluation of physiologic stress responses and digital biomarker forecasting.
High Digital Media Exposure Cohort; Participants with elevated exposure to financial news, algorithmic media feeds, social media platforms, and information-intensive digital environments associated with financial and geopolitical stress signaling.	Device: Wearable Physiologic Monitoring Platform; Commercially available wearable physiologic monitoring devices and digital health technologies will be used to collect continuous or intermittent biometric, cardiovascular, autonomic nervous system, behavioral, and sleep-related data during exposure to financial market volatility, economic uncertainty, and information-driven stress environments. Monitoring technologies may include: wearable ECG devices, heart rate variability (HRV) monitors, blood pressure monitoring systems, sleep tracking devices, galvanic skin response sensors, activity monitoring wearables, voice analysis systems, and optional EEG-enabled wearable technologies. Data generated from these systems will be integrated with artificial intelligence and machine learning-based analytics platforms for evaluation of physiologic stress responses and digital biomarker forecasting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability (HRV) During Financial Stress Exposure	Heart rate variability will be measured using wearable electrocardiographic or photoplethysmographic monitoring devices. HRV will be quantified as the root mean square of successive differences (RMSSD) in milliseconds. Higher RMSSD values generally indicate improved autonomic nervous system flexibility and lower physiologic stress burden.	Baseline through 24 Months
Change in Sleep Duration	Sleep duration will be measured in hours per night using wearable sleep monitoring devices.	Baseline through 24 Months
Change in Resting Heart Rate	Resting heart rate will be measured in beats per minute using wearable biosensor devices.	Baseline through 24 Months
Change in Perceived Stress Scale-10 (PSS-10) Total Score	Perceived stress will be assessed using the validated 10-item Perceived Stress Scale-10 questionnaire. Scores range from 0 to 40, with higher scores indicating greater perceived psychological stress and worse stress-related outcomes.	Baseline through 24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Efficiency	Sleep efficiency percentage measured using wearable sleep tracking systems.	Baseline through 24 Months
Change in Galvanic Skin Response (GSR) Measurements	Electrodermal activity will be measured in microsiemens using wearable biosensor devices to assess sympathetic nervous system activation and physiologic stress responsiveness. Higher values may reflect increased autonomic arousal during stress exposure conditions.	Baseline through 24 Months
Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score	Anxiety symptoms will be assessed using the validated Generalized Anxiety Disorder-7 questionnaire. Scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity and worse psychological outcomes.	Baseline through 24 Months

Collaborators and Investigators

• Sponsor: Truway Health, Inc.
• Investigators: Principal Investigator: Gavin C Solomon, Investigator, Truway Health, Inc.

Publications and helpful links

General Publications

• Cohen S, Janicki-Deverts D, Miller GE. Psychological stress and disease. JAMA. 2007 Oct 10;298(14):1685-7. doi: 10.1001/jama.298.14.1685. No abstract available.
• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
• Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013.
• Thayer JF, Lane RD. The role of vagal function in the risk for cardiovascular disease and mortality. Biol Psychol. 2007 Feb;74(2):224-42. doi: 10.1016/j.biopsycho.2005.11.013. Epub 2006 Dec 19.
• Steptoe A, Kivimaki M. Stress and cardiovascular disease. Nat Rev Cardiol. 2012 Apr 3;9(6):360-70. doi: 10.1038/nrcardio.2012.45.
• Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28.
• McEwen BS. Protective and damaging effects of stress mediators. N Engl J Med. 1998 Jan 15;338(3):171-9. doi: 10.1056/NEJM199801153380307. No abstract available.
• Xiao Y. Bone tissue engineering for dentistry and orthopaedics. Biomed Res Int. 2014;2014:241067. doi: 10.1155/2014/241067. Epub 2014 Nov 26. No abstract available.
• Schneiderman N, Ironson G, Siegel SD. Stress and health: psychological, behavioral, and biological determinants. Annu Rev Clin Psychol. 2005;1:607-28. doi: 10.1146/annurev.clinpsy.1.102803.144141.
• McEwen BS, Gianaros PJ. Stress- and allostasis-induced brain plasticity. Annu Rev Med. 2011;62:431-45. doi: 10.1146/annurev-med-052209-100430.
• Crisostomo PR, Wang M, Herring CM, Markel TA, Meldrum KK, Lillemoe KD, Meldrum DR. Gender differences in injury induced mesenchymal stem cell apoptosis and VEGF, TNF, IL-6 expression: role of the 55 kDa TNF receptor (TNFR1). J Mol Cell Cardiol. 2007 Jan;42(1):142-9. doi: 10.1016/j.yjmcc.2006.09.016. Epub 2006 Oct 30.
• Peters A, McEwen BS. Stress habituation, body shape and cardiovascular mortality. Neurosci Biobehav Rev. 2015 Sep;56:139-50. doi: 10.1016/j.neubiorev.2015.07.001. Epub 2015 Jul 3.
• Solomon G. NeuroFinance Human Stress Trial: AI-Driven Physiologic and Behavioral Response Modeling During Financial Market Volatility and Information-Driven Stress Exposure. Truway Health, Inc. Protocol NFHST-2026-001. New York, NY; 2026.

Helpful Links

• Official study sponsor and clinical research information portal for the NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST-2026-001), including protocol updates, recruitment information, and data sharing policies.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Artificial Intelligence; Machine Learning; Cognitive Performance; Remote Patient Monitoring; Digital Biomarkers; Sleep Monitoring; Emotional Resilience; Decentralized Clinical Trial; Wearable Biosensors; NeuroFinance; Financial Stress Medicine; Behavioral Analytics; Cardiovascular Telemetry; Physiologic Stress; Market Volatility; Economic Uncertainty; Social Media Exposure; Stress Forecasting; Precision Wellness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Occupational Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Burnout, Psychological; Occupational Stress; Financial Stress; Anxiety Disorders; Parasomnias; Sleep Initiation and Maintenance Disorders; Neurobehavioral Manifestations; Stress, Psychological
• Other Study ID Numbers: NFHST-2026-001; Sponsor Protocol Number (Other Identifier: TH-NFHST-2026)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Individual participant data (IPD) collected during this study may be shared with qualified researchers, academic institutions, public health entities, and collaborative research organizations following de-identification and in accordance with applicable privacy, ethical, regulatory, and institutional review board requirements.

Shared datasets may include:

wearable physiologic monitoring data, heart rate variability measurements, sleep monitoring data, behavioral analytics, psychometric assessment results, inflammatory biomarker datasets, and associated digital biomarker outputs.

Data sharing may support future research involving:

stress physiology, cardiovascular health, behavioral medicine, artificial intelligence-assisted predictive analytics, digital biomarker development, decentralized clinical research, neuroeconomics, and public health forecasting systems.

Supporting documents that may be shared include:

study protocol, statistical analysis plan, informed consent templates,

• IPD Sharing Time Frame: Individual participant data (IPD) and supporting study documentation are expected to become available beginning approximately 12 months following publication of the primary study results or completion of the study, whichever occurs first. De-identified datasets and supporting materials may remain available for up to 10 years following study completion, subject to institutional review board requirements, sponsor policies, participant privacy protections, data use agreements, and applicable regulatory requirements.

IPD Sharing Access Criteria

Access to de-identified individual participant data (IPD) and supporting documentation may be provided to qualified researchers, academic institutions, public health organizations, and collaborative research entities whose proposed use is scientifically and ethically appropriate. Requests for access may require submission of a research proposal, statistical analysis plan, institutional affiliation verification, and execution of applicable data use or confidentiality agreements.

Available materials may include:

de-identified participant datasets, wearable physiologic monitoring data, sleep and heart rate variability datasets, biomarker data, study protocol, statistical analysis plan, analytic code, informed consent templates, and associated supporting documentation.

Data access determinations will be reviewed by the study sponsor and applicable oversight processes to ensure participant privacy, ethical compliance, and regulatory alignment.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: NFHST-IPD-2026-001
   Information comments: De-identified participant datasets, wearable physiologic monitoring data, heart rate variability measurements, behavioral analytics outputs, inflammatory biomarker datasets, statistical analysis plans, and analytic code related to the NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST-2026-001) may be made available to qualified researchers upon approval of an appropriate research proposal and execution of applicable data use agreements and institutional review procedures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No