Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2024-12-20

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.

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Detailed Description

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Conditions

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Dehydration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm prospective feasibility study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Wearable bioimpedance sensor

Group Type OTHER

Wearable bioimpedance sensor

Intervention Type DEVICE

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.

Interventions

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Wearable bioimpedance sensor

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.

Intervention Type DEVICE

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes