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

27. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

2500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Gerät: 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.
Gerät: 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.
Gerät: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Heart Rate Variability (HRV) During Financial Stress Exposure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Sleep Efficiency
Zeitfenster: Baseline through 24 Months
Sleep efficiency percentage measured using wearable sleep tracking systems.
Baseline through 24 Months
Change in Galvanic Skin Response (GSR) Measurements
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Truway Health, Inc.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

30. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NFHST-2026-001
  • Sponsor Protocol Number (Andere Kennung: TH-NFHST-2026)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

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-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Studiendaten/Dokumente

  1. Einzelner Teilnehmerdatensatz
    Informationskennung: NFHST-IPD-2026-001
    Informationskommentare: 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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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