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Wearable Tissue Oximetry During Arm Cuff Occlusion, Walking, and Standing Tests in Outpatients With Chronic Heart Failure
Sponsor: NIRSense Inc.
Summary
This prospective, single-center, observational pilot study evaluated an investigational wearable tissue oximeter (NIRSense Argus Oximetry System, also called Envello Core) in adult outpatients with chronic heart failure in New York Heart Association (NYHA) class I, II, or III at Jackson Heart Clinic in Jackson, Mississippi. During one routine clinic visit, participants wore three adhesive optical sensors, on the forearm, the thigh, and the sternum, while completing three standard tests: a blood pressure cuff occlusion of the arm (vascular occlusion test), a six-minute walk test, and a change from lying down to standing. The sensors use near-infrared spectroscopy to record changes in tissue oxygenation. The study compared tissue oxygenation responses across NYHA classes and with standard clinical measures (blood pressure, pulse rate, pulse oximetry, and walk distance). Participation added about 30 minutes to the visit, with no follow-up. Fifty participants were enrolled. No treatment decisions were based on the study device.
Official title: Clinical Evaluation of NIRSense Total Oximetry Monitoring of Cardiopulmonary Function
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2023-11-14
Completion Date
2026-03-15
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Argus Oximetry System
Investigational wearable optical sensors using near-infrared spectroscopy and photoplethysmography to measure tissue oxygenation, pulse oximetry, and pulse rate. Three sensors are applied with a medical-grade adhesive to the dominant forearm, the sternum, and the dominant thigh and worn during a single clinic visit while the participant completes a vascular occlusion test (twice), a six-minute walk test, and a supine-to-standing postural test. Sensor data are collected for research only and are not used for treatment decisions.
Locations (1)
Jackson Heart Clinic
Jackson, Mississippi, United States