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

23. august 2026 oppdatert av: Truway Health, Inc.

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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

2500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10016
        • Truway Health, Inc.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Enhet: 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.
Enhet: 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.
Enhet: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Heart Rate Variability (HRV) During Financial Stress Exposure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Sleep Efficiency
Tidsramme: Baseline through 24 Months
Sleep efficiency percentage measured using wearable sleep tracking systems.
Baseline through 24 Months
Change in Galvanic Skin Response (GSR) Measurements
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Truway Health, Inc.

Etterforskere

  • Hovedetterforsker: Gavin C Solomon, Investigator, Truway Health, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

15. mai 2026

Først innsendt som oppfylte QC-kriteriene

27. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NFHST-2026-001
  • Sponsor Protocol Number (Annen identifikator: TH-NFHST-2026)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Studiedata/dokumenter

  1. Datasett for individuell deltaker
    Informasjonsidentifikator: NFHST-IPD-2026-001
    Informasjonskommentarer: 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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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