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NCT07655401

Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring

Sponsor: Mode Sensors AS

View on ClinicalTrials.gov

Summary

The purpose of the project is to validate the performance of a wearable bioimpedance sensor (Re:Balans®) for monitoring hydration status. The study includes hospitalized patients aged 65 years or older who are admitted to the hospital with suspected dehydration. Data will be collected continuously throughout the hospital stay using one sensor placed on the back, one on the upper arm, and one on the front of the thigh. Sensor measurements will be compared with multiple reference methods for assessing hydration status, including blood tests, body weight and fluid balance charts. Agreement with these reference measures will form the basis for the performance evaluation. The anticipated benefit of the project is the validation of a novel, user-friendly, and non-invasive tool for hydration monitoring, with the aim of improving patient care, preventing complications, and reducing the need for hospital readmissions.

Official title: Validation of a Wearable Bioimpedance Sensor for Non-Invasive Monitoring of Hydration Status

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-08

Completion Date

2027-03-31

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DEVICE

Bioimpedance sensor

Subjects will wear three bioimpedance sensors throughout their stay at the hospital

Locations (1)

St. Olavs hospital

Trondheim, Trøndelag, Norway