Truway Health, Inc.
TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin. The digital twin will combine measurements from multiple body systems to create a participant-specific representation of physiologic state, resilience, and recovery. The study plans to enroll approximately 450 adults between 18 and 80 years of age. Participants will include generally healthy adults and adults with stable cardiometabolic, respiratory, or mobility-related conditions. Study measurements may include wearable-sensor data, heart rate and rhythm, blood pressure, oxygen saturation, autonomic responses, body composition, mobility, muscle function, sleep, activity, cognitive performance, point-of-care imaging, laboratory measurements, and optional biospecimens. Participants will complete a standardized resilience assessment consisting of rest, active standing, a six-minute walk, a cognitive dual task, and monitored recovery. Selected measurements will also be collected during home monitoring and follow-up visits for up to 12 months. The primary objective is to determine how accurately a locked digital-twin model predicts Whole-Body Recovery Burden, a research measure derived from the timing and magnitude of recovery across several physiologic systems. Model development and testing will be separated so that the final evaluation is performed in an independent validation cohort. This study does not assign participants to a medical treatment. Digital-twin outputs will not be used to diagnose disease, recommend treatment, or replace evaluation by a qualified health care professional.
Human physiologic resilience depends on coordinated responses across the cardiovascular, respiratory, autonomic, metabolic, musculoskeletal, sensory, immune, behavioral, and environmental domains. Conventional clinical measurements generally evaluate these systems separately and at isolated points in time. TRU-OMNIBODY will investigate whether multimodal longitudinal measurements can be integrated into a participant-specific digital twin that represents whole-body physiologic reserve and recovery dynamics. The study is designed as a prospective observational development-and-external-validatio…
Inclusion Criteria: * Age 18 through 80 years at enrollment. * Able and willing to provide written informed consent. * Able to understand study instructions and comply with protocol assessments. * Able to complete the standardized physiologic resilience challenge safely, with a customary assistive device or protocol-permitted accommodation when needed. * Clinically stable at screening, with no significant acute change in health status or prescribed medication regimen during the preceding 30 days, unless determined by the investigator not to affect participant safety or study measurements. * W…
Participants will complete a standardized, nontherapeutic sequence that may include baseline rest and stabilization, active standing, a six-minute walk, a cognitive dual task, and monitored recovery. Synchronized physiologic and functional measurements will be collected before, during, and after the challenge to quantify response magnitude, cross-system coordination, and recovery kinetics. This procedure is performed for observational research and does not assign treatment.
Participants will undergo multimodal longitudinal monitoring using research assessments that may include wearable sensors, electrocardiography, blood pressure, pulse oximetry, respiratory measurements, body composition, sleep and activity monitoring, mobility testing, symptom assessments, and point-of-care imaging. Measurements will be synchronized when feasible to characterize whole-body physiologic state and change over time. Study-generated measurements are observational and will not be used to direct treatment.
A version-controlled computational model will integrate each participant's longitudinal physiologic, functional, clinical, imaging, wearable, and optional biospecimen-derived data. The model will estimate whole-body resilience, organ-system interactions, physiologic reserve, and recovery trajectories. Model development will use a prespecified training sample, followed by locked validation in an independent sample. Digital-twin outputs are investigational, research-only, and will not be used for diagnosis or clinical decision-making.