Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorMode Sensors AS

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 65 years

Planned fluid management due to presumed dehydration

Expected duration of hospital stay ≥ 3 days

Disqualifiers

Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives

Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.

Scheduled MRI

Scheduled diathermy

Trial design

Treatments tested in this trial

  • Bioimpedance sensor

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mode Sensors AS

Lead sponsor

St. Olavs Hospital

Collaborator