Multimodal Physiologic Signal Fusion for 72-Hour Prediction of Acute Clinical Deterioration
| Registry | NCT07817550, acronym FUSION-72 |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 10000 (Estimated) |
| Sponsor | Truway Health, Inc. (Industry) |
| Conditions | Acute Disease, Disease Progression, Critical Illness, Biomarkers, Aging, Digital Health, Wearable Electronic Devices, Remote Patient Monitoring |
| Interventions | Multimodal Digital Biomarker Monitoring (Other) |
| Dates | start 2026-09-01, primary completion 2038-09-30 (estimated), completion 2039-03-31 (estimated), first posted 2026-09-14, last updated 2026-09-14 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Disease All trials for Disease Progression All trials of Multimodal Digital Biomarker Monitoring
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.
FUSION-72 (Multimodal Physiologic Signal Fusion for 72-Hour Prediction of Acute Clinical Deterioration) is a prospective, longitudinal, observational study designed to investigate multimodal digital biomarkers associated with acute clinical deterioration. The central scientific premise is that clinically meaningful deterioration may be preceded not only by an abnormal value in an individual physiologic parameter, but also by coordinated or discordant changes occurring across multiple physiologic, behavioral, and symptom domains.
The study will collect longitudinal data from multiple digital and physiologic sources, which may include wearable electrocardiography (ECG), photoplethysmography (PPG), peripheral oxygen saturation (SpO2), temperature, gait and activity characteristics, sleep measures, voice characteristics, cough characteristics, and participant-reported symptoms.
These multimodal measurements will be temporally aligned and analyzed to characterize changes within individual participants and relationships among physiologic, behavioral, acoustic, and symptom-derived signals. Analyses will evaluate whether multimodal signal fusion provides additional predictive information beyond individual digital biomarker streams or conventional single-parameter measurements.
The primary objective is to evaluate the predictive accuracy of a prespecified multimodal digital biomarker model for protocol-defined acute clinical deterioration occurring within a subsequent 72-hour prediction window. Secondary objectives include evaluation of time-dependent predictive performance, lead time to detection, incremental predictive value of multimodal signal relationships, model calibration, and robustness of predictive performance across prespecified participant and clinical subgroups.
The study is observational. No investigational treatment is assigned, and participation does not direct, replace, or require modification of usual clinical care or medical management.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| FUSION-72 Prospective Multimodal Monitoring Cohort | Other: Multimodal Digital Biomarker Monitoring | 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. |
Sex: All, ages: 18 Years to 90 Years
Inclusion Criteria: * Adults aged 18 through 90 years at enrollment. * Able to provide informed consent, or have a legally authorized representative provide consent when permitted by the applicable protocol and regulations. * Able and willing to participate in prospective longitudinal digital biomarker monitoring. * Able to use, or permit application of, study-authorized wearable or remote-monitoring technologies. * Able and willing to provide protocol-specified physiologic, behavioral, acoustic, and symptom data. * Expected to have sufficient follow-up to permit evaluation of the 72-hour prediction endpoint. * Willing to comply with study procedures and data-collection requirements. Exclusion Criteria: * Inability to provide informed consent or otherwise participate through an approved consent process. * Clinical or technical circumstances that prevent reliable collection of the required multimodal digital biomarker data. * Inability or unwillingness to comply with study monitoring procedures. * Enrollment in another study that, in the investigator's judgment, would materially interfere with FUSION-72 data collection or endpoint assessment. * Any circumstance that, in the investigator's judgment, would make participation inappropriate or compromise the integrity of the study.
| Facility | City | Country | Status |
|---|---|---|---|
| Truway Health, Inc. | New York, New York | United States |