Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring

NCT07655401 | Not Yet Recruiting FDA Device

• 1 other identifier: CTR0062A VAMOS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Dehydration; Hypovolemia

Outcome Measures

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

  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

  Once daily during hospital stay, assessed up to 7 days

• Sensitivity/specificity at the three placements

  Once daily during hospital stay, assessed up to 7 days

• Sensitivity/specificity of different device outputs

  Once daily during hospital stay, assessed up to 7 days

• Correlation between device output and reference measurements

  Day 1 and day of discharge (up to 1 week)

• User satisfaction among patients

  Day 3

Study Arms (1)

Dehydrated patients

The cohort includes individuals 65 years or older admitted to the hospital with dehydration

Device: Bioimpedance sensor

Interventions

Bioimpedance sensor DEVICE

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

Dehydrated patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥ 65 years
• Planned fluid management due to presumed dehydration
• Expected duration of hospital stay ≥ 3 days

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mode Sensors AS: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs hospital

Trondheim, Trøndelag, 7030, Norway

Location

MeSH Terms

Conditions

Dehydration; Hypovolemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigve N Aas, PhD

  Mode Sensors AS

  STUDY DIRECTOR

Central Study Contacts

Sigve N Aas, PhD

CONTACT

004741499074; sigve.aas@modesensors.com

Frida Bremnes, MSc

CONTACT

frida.bremnes@modesensors.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)