NeuroFinance Human Stress Trial During Financial and Informational Volatility

Official title

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

Overview

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.

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.

Interventions

• 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 de

Primary outcome measures

• Change in Heart Rate Variability (HRV) During Financial Stress Exposure [Time frame: Baseline through 24 Months]
• Change in Sleep Duration [Time frame: Baseline through 24 Months]
• Change in Resting Heart Rate [Time frame: Baseline through 24 Months]
• Change in Perceived Stress Scale-10 (PSS-10) Total Score [Time frame: Baseline through 24 Months]

Secondary outcome measures (3)

• Change in Sleep Efficiency [Time frame: Baseline through 24 Months]
• Change in Galvanic Skin Response (GSR) Measurements [Time frame: Baseline through 24 Months]
• Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score [Time frame: Baseline through 24 Months]

Eligibility criteria

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.

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

• Truway Health, Inc. — New York

Publications

• 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. PMID 25525594
• 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. PMID 17716101
• 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. PMID 24194703
• McEwen BS, Gianaros PJ. Stress- and allostasis-induced brain plasticity. Annu Rev Med. 2011;62:431-45. doi: 10.1146/annurev-med-052209-100430. PMID 20707675
• 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. PMID 29034226
• 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. PMID 17925521
• Steptoe A, Kivimaki M. Stress and cardiovascular disease. Nat Rev Cardiol. 2012 Apr 3;9(6):360-70. doi: 10.1038/nrcardio.2012.45. PMID 22473079
• 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. PMID 29486547

Identifiers

NCT: NCT07622589 · NFHST-2026-001 · Sponsor Protocol Number

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗