Multimodal Digital Biomarker Prediction of Acute Clinical Deterioration

Part of paid clinical trials in New York, New York.

Sponsor
Truway Health, Inc.
Study ID
NCT07817550
Status
Enrolling By Invitation

Conditions

  • Acute Disease
  • Aging
  • Biomarkers
  • Critical Illness
  • Digital Health
  • Disease Progression
  • Remote Patient Monitoring
  • Wearable Electronic Devices

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Multimodal Digital Biomarker Monitoring — OTHER
    Prospective collection and analysis of multimodal digital biomarkers derived from wearable and remote-monitoring technologies, including ECG, PPG, oxygen saturation, temperature, gait, sleep, voice, cough, and participant-reported symptom data. The monitoring is observational and does not direct or replace clinical care, does not assign treatment, and does not require modification of participants' usual medical management. Multimodal signals will be temporally aligned and evaluated for changes in inter-signal relationships associated with protocol-defined clinical deterioration occurring within the subsequent 72-hour prediction window.

Study Details

Rather than relying on a single abnormal vital sign, the study will examine how multiple physiologic signals change together over time and whether changes in the relationships among these signals provide useful information about impending clinical deterioration. Individual participant physiologic patterns may be characterized longitudinally to account for differences between individuals and changes within the same individual over time. The primary objective is to evaluate the predictive accuracy of multimodal digital biomarkers for protocol-defined acute clinical deterioration occurring within 72 hours. The study is observational and does not assign participants to an investigational treatment.

Key Dates

First listed
Sep 14, 2026
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2038
Completion
Mar 31, 2039

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: FUSION-72 Prospective Multimodal Monitoring Cohort
    Participants enrolled in a prospective longitudinal observational cohort undergoing multimodal digital biomarker monitoring. Participants will contribute wearable and digital measurements including electrocardiography (ECG), photoplethysmography (PPG), oxygen saturation, temperature, gait, sleep, voice, cough, and participant-reported symptoms. Data will be analyzed longitudinally to characterize temporal changes and relationships among physiologic and behavioral signals and to evaluate prediction of protocol-defined acute clinical deterioration within 72 hours. No investigational treatment or therapeutic intervention is assigned by the study.

Primary Outcome Measure

Predictive Accuracy of Multimodal Digital Biomarker Fusion for Acute Clinical Deterioration Within 72 Hours [ Time Frame: At initiation of each prespecified prediction episode and 72 hours after initiation of each prespecified prediction episode. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Truway Health, Inc.New YorkNew York10016-

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