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Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring

NCT07655401 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Bioimpedance sensor

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

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Mode Sensors AS

    lead INDUSTRY

Principal Investigators

  • Sigve N Aas, PhD · Mode Sensors AS

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-03-15
Completion
2027-03-31
FDA Device
Yes

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655401 on ClinicalTrials.gov