DehydrationVAMOSNCT07655401
Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring
An observational study of Dehydration and Hypovolemia, run by Mode Sensors AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dehydration, Hypovolemia
- What is being tested?
- Bioimpedance sensor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study 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.
Who may be able to join
- Age ≥ 65 years
- Planned fluid management due to presumed dehydration
- Expected duration of hospital stay ≥ 3 days
Who cannot join
- 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
- Breached skin at device application areas (upper back, anterior thigh and upper arm)
- Unconsciousness
Show all 9Show fewer
- Critically ill (presence of acute organ dysfunction requiring intensive monitoring and management)
- Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
- Incapable of giving informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Frida Bremnes, MSc contact
Norway1 site
St. Olavs hospital
Trondheim, Trøndelag, 7030
Lars P Bjørnsen, PhD, 004793212617, lars.petter.bache-wiig.bjornsen@stolav.no
Lars P Bjørnsen, PhD
About this study
Official title: Validation of a Wearable Bioimpedance Sensor for Non-Invasive Monitoring of Hydration Status
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.
Read the detailed description
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.
- Conditions
- Dehydration, Hypovolemia
- Being tested
- Bioimpedance sensor
- Medical subject headings
- Dehydration, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance sensorDevice
Subjects will wear three bioimpedance sensors throughout their stay at the hospital
| Study group | Role | What they receive |
|---|---|---|
| Dehydrated patients | The cohort includes individuals 65 years or older admitted to the hospital with dehydration Receives: Device: Bioimpedance sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 and day of discharge (up to 1 week)
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startAug 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Sigve N Aas, PhD, Study director, Mode Sensors AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655401
- Sponsor's protocol ID
- CTR0062A VAMOS
- Acronym
- VAMOS
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Wearable Bioimpedance Sensor for Non-Invasive Monitoring of Hydration Status
- ClinicalTrials.gov ID
- NCT07655401
- Acronym / sponsor ID
- VAMOS / CTR0062A VAMOS
- Conditions
- Dehydration, Hypovolemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dehydrated patients | – | Device: Bioimpedance sensorThe cohort includes individuals 65 years or older admitted to the hospital with dehydration |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- Planned fluid management due to presumed dehydration
- Expected duration of hospital stay ≥ 3 days
Key exclusion criteria (9 listed)
- 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
- Breached skin at device application areas (upper back, anterior thigh and upper arm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioimpedance sensorSubjects will wear three bioimpedance sensors throughout their stay at the hospital | Device | Dehydrated patients |
Primary outcome
Relative change in device output from admission to discharge
Time frame: Day 1 and day of discharge (up to 1 week)
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
5 secondary outcomes
Sensitivity/specificity of the device for the detection of significant fluid volume changes
Time frame: Once daily during hospital stay, assessed up to 7 days
Sensitivity/specificity at the three placements
Time frame: Once daily during hospital stay, assessed up to 7 days
Sensitivity/specificity of different device outputs
Time frame: Once daily during hospital stay, assessed up to 7 days
Correlation between device output and reference measurements
Time frame: Day 1 and day of discharge (up to 1 week)
User satisfaction among patients
Time frame: Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration & Female Life Stages
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frida Bremnes, MSc contact
Sigve N Aas, PhD study director
Mode Sensors AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration and Hypovolemia, run by Mode Sensors AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigve N Aas, PhD (004741499074, sigve.aas@modesensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in device output from admission to discharge (time frame: Day 1 and day of discharge (up to 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.