NeuroFinance Human Stress Trial During Financial and Informational Volatility

NCT07622589 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: NFHST-2026-001Sponsor Protocol Number
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Stress; Anxiety; Emotional Stress; Sleep Disturbance; Behavioral Health; Occupational Stress; Financial Stress; Burnout Syndrome; Insomnia; Cognitive Fatigue; Neurobehavioral Manifestations; Autonomic Nervous System Dysfunction; Heart Rate Variability

Keywords

NeuroFinance; Financial Stress Medicine; Wearable Biosensors; Artificial Intelligence; Machine Learning; Digital Biomarkers; Heart Rate Variability; Sleep Monitoring; Behavioral Analytics; Cardiovascular Telemetry; Decentralized Clinical Trial; Emotional Resilience; Physiologic Stress; Market Volatility; Economic Uncertainty; Social Media Exposure; Cognitive Performance; Stress Forecasting; Precision Wellness; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in Sleep Efficiency

  Baseline through 24 Months

• Change in Galvanic Skin Response (GSR) Measurements

  Baseline through 24 Months

• Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score

  Baseline through 24 Months

Study Arms (4)

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

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

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

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

Interventions

Wearable Physiologic Monitoring Platform DEVICE

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; General Population Control Cohort; High Digital Media Exposure Cohort; Retail Investors / Active Traders Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

Truway Health, Inc.

New York, New York, 10016, United States

Location

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 17070836 BACKGROUND

• 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.

  PMID: 9428819 BACKGROUND

• 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.

  PMID: 26148986 BACKGROUND

• 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.

  PMID: 17182165 BACKGROUND

• 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.

  BACKGROUND

Related 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.

Biospecimen

Retention: SAMPLES WITH DNA

Optional biospecimens retained under this protocol may include: salivary cortisol samples, peripheral blood samples for inflammatory biomarker and cytokine analysis, genomic and epigenetic research specimens, dried blood spot collections, and associated de-identified biologic derivatives generated during laboratory analysis. Samples may be used for future research involving stress physiology, autonomic nervous system regulation, cardiovascular stress response, behavioral health analytics, inflammatory signaling, digital biomarker development, and artificial intelligence-assisted predictive modeling related to physiologic responses to financial and informational stress exposure.

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Parasomnias; Sleep Initiation and Maintenance Disorders; Occupational Stress; Financial Stress; Burnout, Psychological; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Occupational Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavin C Solomon, Investigator

  Truway Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gavin C Solomon, Investigator

CONTACT

15167685264; gavin@truwayhealth.com

Dr. Alicia Levin, M.D.

CONTACT

1-833-TRUWAY-1; irb@truwayhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)