Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring (VAMOS)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Sigve N Aas, PhD
- Telefonnummer: 004741499074
- E-post: sigve.aas@modesensors.com
Studer Kontakt Backup
- Navn: Frida Bremnes, MSc
- E-post: frida.bremnes@modesensors.com
Studiesteder
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Trøndelag
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Trondheim, Trøndelag, Norge, 7030
- St. Olavs Hospital
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Ta kontakt med:
- Lars P Bjørnsen, PhD
- Telefonnummer: 004793212617
- E-post: lars.petter.bache-wiig.bjornsen@stolav.no
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Hovedetterforsker:
- Lars P Bjørnsen, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Dehydrated patients
The cohort includes individuals 65 years or older admitted to the hospital with dehydration
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Subjects will wear three bioimpedance sensors throughout their stay at the hospital
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Relative change in device output from admission to discharge
Tidsramme: Day 1 and day of discharge (up to 1 week)
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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
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Day 1 and day of discharge (up to 1 week)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sensitivity/specificity of the device for the detection of significant fluid volume changes
Tidsramme: Once daily during hospital stay, assessed up to 7 days
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Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
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Once daily during hospital stay, assessed up to 7 days
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Sensitivity/specificity at the three placements
Tidsramme: Once daily during hospital stay, assessed up to 7 days
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Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
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Once daily during hospital stay, assessed up to 7 days
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Sensitivity/specificity of different device outputs
Tidsramme: Once daily during hospital stay, assessed up to 7 days
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Proportion of true positives (changed hydration) and true negatives (unchanged hydration) correctly identified by the device
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Once daily during hospital stay, assessed up to 7 days
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Correlation between device output and reference measurements
Tidsramme: Day 1 and day of discharge (up to 1 week)
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Correlation between changes in device output and reference measurements during the hospital stay
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Day 1 and day of discharge (up to 1 week)
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User satisfaction among patients
Tidsramme: Day 3
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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.
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Day 3
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Sigve N Aas, PhD, Mode Sensors AS
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CTR0062A VAMOS
Plan for individuelle deltakerdata (IPD)
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