Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)

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

Sponsor
Truway Health, Inc.
Study ID
NCT07805044
Status
Enrolling By Invitation

Conditions

  • Cardiometabolic Risk Factors
  • Cardiorespiratory Fitness
  • Homeostasis
  • Mobility Limitation
  • PHYSIOLOGICAL PHENOMENA
  • Physical Functional Performance

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Standardized Physiologic Resilience Challenge — PROCEDURE
    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.
  • Multimodal Whole-Body Physiologic Monitoring — OTHER
    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.
  • Research-Only Whole-Body Digital Twin Analysis — OTHER
    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.

Study Details

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.

Key Dates

First listed
Sep 4, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2039
Completion
Jun 30, 2041

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: Reference Health Cohort
    Approximately 150 generally healthy adults will be observed to establish reference patterns of whole-body physiology, cross-organ coordination, functional capacity, and recovery following a standardized physiologic challenge. Participants will undergo the same research assessments and longitudinal monitoring as the other cohorts. No treatment will be assigned or modified by the study.
  • Arm: Stable Cardiometabolic Cohort
    Approximately 150 adults with stable cardiometabolic conditions or risk factors, which may include controlled hypertension, dyslipidemia, obesity, prediabetes, or stable type 2 diabetes, will be observed. The study will characterize physiologic response, cross-system coordination, and recovery in comparison with the reference cohort. No treatment will be assigned or modified by the study.
  • Arm: Stable Respiratory or Mobility Cohort
    Approximately 150 adults with stable chronic respiratory conditions or mobility-related functional limitations will be observed. Eligible participants must be clinically stable and able to complete the study assessments safely, with protocol-permitted accommodations when needed. The study will characterize functional reserve, physiologic response, and recovery in comparison with the other cohorts. No treatment will be assigned or modified by the study.

Primary Outcome Measure

Mean Absolute Prediction Error of the Locked Digital Twin for the 30-Minute Whole-Body Resilience Index [ Time Frame: During the primary assessment visit, from pre-challenge baseline through 30 minutes after completion of the resilience challenge. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Truway Health, Inc.New YorkNew York10016-

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