Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals

Dehydration Clinical Trial

— HELD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831800
• Other study ID #: CTR0061A HELD
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: June 2023
• Source: Mode Sensors AS
• Contact: Sigve N Aas, PhD
• Phone: 004741499074
• Email: sigve.aas[@]modesensors.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dehydration

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Norway	Tempe Helse- og velferdssenter	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Mode Sensors AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean use time of the wearable sensor		Up to 7 days
Secondary	The mean number of days the sensor provides valid measurements		Up to 7 days
Secondary	Mean and standard deviation of the device output variables		Up to 7 days
Secondary	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
Secondary	Clinical assessment of hydration status		Day 1, 8, 15, 22, 29
Secondary	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
Secondary	Frequency and severity of adverse device effects		Day 1-30