Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals

Not Applicable

Recruiting

• Conditions: Dehydration
• Interventions: Device: Wearable bioimpedance sensor

• Registration Number: NCT05831800
• Lead Sponsor: Mode Sensors AS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Status Verified: 2023-06
• Study Start: 2023-06-14
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wearable bioimpedance sensor	Wearable bioimpedance sensor	-

Primary Outcome Measures

Name	Time	Method
Mean use time of the wearable sensor	Up to 7 days

Secondary Outcome Measures

Name	Time	Method
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	Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement.
Mean and standard deviation of the device output variables	Up to 7 days
User satisfaction	Day 8, 15, 22, 29	Will be assessed using a likert scale from 1-5, where 1 represents "strongly disagree" and 5 represents "strongly agree".

Trial Locations

Locations (1)

Tempe Helse- og velferdssenter; 🇳🇴 Trondheim, Norway