NCT06003205

Contributing Factors to Local Bioimpedance Spectroscopy

Assessment of Contributing Factors to Local Bioimpedance Spectroscopy Using a Wearable Sensor: An Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mode Sensors AS · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an exploratory interventional study. The aim of the investigation is to identify and quantify contributing factors to local bioimpedance spectroscopy (BIS) measured by a wearable sensor patch, particularly the effect of fluid shifts caused by postural changes and lower body negative pressure (LBNP).

Detailed description

The investigational devices (patches) will perform near-continuous measurements of multifrequency bioimpedance (BIS), temperature, and body orientation (accelerometer) during the entire period of wear (2 days). Patches will be mounted at the upper body (back and thorax) and calf. The primary objective is to assess the effect of prolonged lower body negative pressure (LBNP) on the BIS of the calf. The target population is healthy volunteers between 18-50 years old.

Conditions

• Fluid and Electrolyte Imbalance
• Overhydration
• Edema

Interventions

Type	Name	Description
DEVICE	Wearable bioimpedance sensor	The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid volume. It is designed as an adhesive patch with four integrated electrodes.

Timeline

• Start date: 2023-09-04
• Primary completion: 2023-09-14
• Completion: 2023-09-14
• First posted: 2023-08-21
• Last updated: 2024-03-12

Locations

1 site across 1 country: Norway