Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals

Study Overview
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Brief Summary
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This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.

Official Title
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Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study

Conditions
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Dehydration

Intervention / Treatment
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* Device: Wearable bioimpedance sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years Exclusion Criteria: Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives Non-intact skin such as skin breakdown where the device is to be placed (upper back) Implantable pulse generators such as pacemakers and defibrillators Any medical or psychiatric condition, which in the opinion of the investigator precludes participation

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm prospective feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wearable bioimpedance sensor<br> | Device: Wearable bioimpedance sensor<br>* The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid balance. It is designed as an adhesive patch with four integrated electrodes. The outer electrodes are used to supply a low current, while the inner electrodes are used for voltage measurements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean use time of the wearable sensor |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean number of days the sensor provides valid measurements |  | Up to 7 days | 
| Mean and standard deviation of the device output variables |  | Up to 7 days | 
| Stability of device measurements following weekly patch replacement | Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement. | Day 8, 15, 22, 29 | 
| Clinical assessment of hydration status |  | Day 1, 8, 15, 22, 29 | 
| User satisfaction | Will be assessed using a likert scale from 1-5, where 1 represents strongly disagree and 5 represents strongly agree. | Day 8, 15, 22, 29 | 
| Frequency and severity of adverse device effects |  | Day 1-30 |