NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST)
NeuroFinance Human Stress Trial During Financial and Informational Volatility (NFHST)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
-
-
New York
-
New York, New York, Verenigde Staten, 10016
- Truway Health, Inc.
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Heart Rate Variability (HRV) During Financial Stress Exposure
Tijdsspanne: Baseline through 24 Months
|
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
Tijdsspanne: Baseline through 24 Months
|
Sleep duration will be measured in hours per night using wearable sleep monitoring devices.
|
Baseline through 24 Months
|
|
Change in Resting Heart Rate
Tijdsspanne: Baseline through 24 Months
|
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
Tijdsspanne: Baseline through 24 Months
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Sleep Efficiency
Tijdsspanne: Baseline through 24 Months
|
Sleep efficiency percentage measured using wearable sleep tracking systems.
|
Baseline through 24 Months
|
|
Change in Galvanic Skin Response (GSR) Measurements
Tijdsspanne: Baseline through 24 Months
|
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
Tijdsspanne: Baseline through 24 Months
|
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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gavin C Solomon, Investigator, Truway Health, Inc.
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Hartslagvariabiliteit
- Kunstmatige intelligentie
- Machinaal leren
- Cognitieve prestaties
- Patiëntbewaking op afstand
- Digitale biomarkers
- Slaapmonitoring
- Emotionele veerkracht
- Gedecentraliseerde klinische proef
- Draagbare biosensoren
- NeuroFinance
- Financial Stress Medicine
- Behavioral Analytics
- Cardiovascular Telemetry
- Physiologic Stress
- Market Volatility
- Economic Uncertainty
- Social Media Exposure
- Stress Forecasting
- Precision Wellness
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Gedragssymptomen
- Slaap-waakstoornissen
- Slaapstoornissen, intrinsiek
- Dyssomnieën
- Beroepsziekten
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Burn-out, psychisch
- Beroepsmatige spanning
- Financiële stress
- Angst stoornissen
- Parasomnieën
- Slaapinitiatie en -onderhoudsstoornissen
- Neurologische gedragsmanifestaties
- Stress, psychisch
Andere studie-ID-nummers
- NFHST-2026-001
- Sponsor Protocol Number (Andere identificatie: TH-NFHST-2026)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Bestudeer gegevens/documenten
-
Gegevensset individuele deelnemers
Informatie-ID: NFHST-IPD-2026-001Informatie opmerkingen: 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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .