An observational study in Dehydration and Hypovolemia, sponsored by Mode Sensors AS. Not yet recruiting at 1 site in Norway. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Mode Sensors AS · Observational
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.
The study aims to evaluate how well a wearable bioimpedance sensor (Re:Balans®) tracks changes in hydration status in hospitalized patients. The objective is to validate the sensor's ability to provide continuous, non-invasive monitoring of fluid balance, which may improve the management and treatment of patients at risk of dehydration or fluid overload. Such a solution could also help reduce the need for hospital admissions and in-person follow-up visits.
The investigation is designed as a prospective cohort study in which patients are followed throughout their hospital stay, typically lasting 3-7 days. Participants will wear three sensors, placed on the upper back, upper arm, and anterior thigh. The sensors automatically perform measurements every minute during the study period.
At baseline and during daily follow-up visits, several assessments of hydration status will be performed. These include body weight measurements, blood tests, and whole-body bioimpedance measurements. In a subgroup of patients, ultrasound assessment of the inferior vena cava will also be performed. The combined results from these assessments will serve as reference measures to determine whether the patient's hydration status has changed over time.
At hospital discharge, the assessments are repeated, the sensors are removed, and participants complete a short questionnaire regarding their experience with the device. In addition, fluid balance data (fluid intake and output) will be collected retrospectively from medical records to allow comparison between the sensor measurements and routine clinical monitoring methods. Relevant clinical information obtained as part of standard patient care will also be recorded if considered important for the assessment of hydration status.
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's planned enrollment of 60 is below the median of 105 across 46 observational studies indexed under Dehydration.
Browse Dehydration studies →Mode Sensors AS is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The cohort includes individuals 65 years or older admitted to the hospital with dehydration
Device: Bioimpedance sensor
Subjects will wear three bioimpedance sensors throughout their stay at the hospital
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)
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 days
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 days
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 days
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)
User satisfaction among patients
Subjects will respond to a questionnaire related to user comfort. The questionnaire uses a 5-point Likert scale ranging from 1 to 5, where lower scores indicate better outcomes and higher scores indicate worse outcomes. The questionnaire will be filled out on day 3 of the hospital stay.
Time frame: Day 3
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Mar 2027, 7 months later.
Of 19 observational studies under Dehydration, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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