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

Mode Sensors AS1 site in 1 country40 target enrollmentJune 14, 2023

ConditionsDehydration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dehydration
Sponsor: Mode Sensors AS
Enrollment: 40
Locations: 1
Primary Endpoint: Mean use time of the wearable sensor
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 14, 2023

End Date

December 20, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mode Sensors AS

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean use time of the wearable sensor

Time Frame: Up to 7 days

Secondary Outcomes

Clinical assessment of hydration status(Day 1, 8, 15, 22, 29)
The mean number of days the sensor provides valid measurements(Up to 7 days)
Frequency and severity of adverse device effects(Day 1-30)
Stability of device measurements following weekly patch replacement(Day 8, 15, 22, 29)
Mean and standard deviation of the device output variables(Up to 7 days)
User satisfaction(Day 8, 15, 22, 29)