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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of hospitalized patients aged 65 years or older who are admitted with suspected dehydration and are planned to receive fluid therapy. Participants may have varying underlying medical conditions and comorbidities that could influence hydration status during their hospital stay.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bioimpedance sensor
DeviceSubjects will wear three bioimpedance sensors throughout their stay at the hospital
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Dehydrated patients1 intervention
Trial outcomes
Primary outcomes
1
Relative change in device output from admission to discharge
Relative change in device output from admission to discharge in patients with a confirmed increase in fluid volume, compared with subjects whose hydration status remain stable
Time frame
Day 1 and day of discharge (up to 1 week)Secondary outcomes
1
Sensitivity/specificity of the device for the detection of significant fluid volume changes
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
Time frame
Once daily during hospital stay, assessed up to 7 days2
Sensitivity/specificity at the three placements
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
Time frame
Once daily during hospital stay, assessed up to 7 days3
Sensitivity/specificity of different device outputs
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
Time frame
Once daily during hospital stay, assessed up to 7 days4
Correlation between device output and reference measurements
Correlation between changes in device output and reference measurements during the hospital stay
Time frame
Day 1 and day of discharge (up to 1 week)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mode Sensors AS
Lead sponsor
St. Olavs Hospital
Collaborator
Source ClinicalTrials.gov
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