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

2026年8月23日 更新者：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.

調査の概要

状態

招待による登録

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

2500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • New York
      • New York、New York、アメリカ、10016
        • Truway Health, Inc.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
デバイス：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.
デバイス：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.
デバイス：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Heart Rate Variability (HRV) During Financial Stress Exposure
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Sleep Efficiency
時間枠：Baseline through 24 Months
Sleep efficiency percentage measured using wearable sleep tracking systems.
Baseline through 24 Months
Change in Galvanic Skin Response (GSR) Measurements
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Truway Health, Inc.

捜査官

  • 主任研究者：Gavin C Solomon, Investigator、Truway Health, Inc.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月15日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2029年6月30日

試験登録日

最初に提出

2026年5月15日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月25日

QC基準を満たした最後の更新が送信されました

2026年8月23日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NFHST-2026-001
  • Sponsor Protocol Number (その他の識別子：TH-NFHST-2026)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

試験データ・資料

  1. 個人参加者データセット
    情報識別子：NFHST-IPD-2026-001
    情報コメント：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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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