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Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring (VAMOS)

15. juni 2026 opdateret af: Mode Sensors AS

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Dehydrated patients
The cohort includes individuals 65 years or older admitted to the hospital with dehydration
Enhed: Bioimpedance sensor
Subjects will wear three bioimpedance sensors throughout their stay at the hospital

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative change in device output from admission to discharge
Tidsramme: 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
Day 1 and day of discharge (up to 1 week)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity/specificity of the device for the detection of significant fluid volume changes
Tidsramme: Once daily during hospital stay, assessed up to 7 days
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
Once daily during hospital stay, assessed up to 7 days
Sensitivity/specificity at the three placements
Tidsramme: Once daily during hospital stay, assessed up to 7 days
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
Once daily during hospital stay, assessed up to 7 days
Sensitivity/specificity of different device outputs
Tidsramme: Once daily during hospital stay, assessed up to 7 days
Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
Once daily during hospital stay, assessed up to 7 days
Correlation between device output and reference measurements
Tidsramme: Day 1 and day of discharge (up to 1 week)
Correlation between changes in device output and reference measurements during the hospital stay
Day 1 and day of discharge (up to 1 week)
User satisfaction among patients
Tidsramme: Day 3
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.
Day 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mode Sensors AS

Samarbejdspartnere

St. Olavs Hospital

Efterforskere

  • Studieleder: Sigve N Aas, PhD, Mode Sensors AS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

15. marts 2027

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CTR0062A VAMOS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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