Contributing Factors to Local Bioimpedance Spectroscopy

Edema Clinical Trial

— COBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003205
• Other study ID #: DOC1040A COBI
• Status: Completed
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: September 14, 2023

Study information

• Verified date: March 2024
• Source: Mode Sensors AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 to 50 years of age, at the time of signing the informed consent

• Overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound.

• Use of adequate birth control for women of childbearing potential. Inclusion is possible when an acceptable effective contraceptive measure is used (combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

• Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives

• Breached skin at patch mounting area.

• Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.

• Planned magnetic resonance (MR) imaging during the investigation period

• Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).

• Pregnancy

• Breastfeeding

• History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).

• Any known cardiac disease that, at the investigator's discretion, warrants exclusion from the study, including but not limited to cardiac arrhythmia, esophageal varices, and aneurysms.

Related Conditions & MeSH terms

• Edema
• Fluid and Electrolyte Imbalance
• Overhydration
• Water Intoxication

Intervention

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.

Locations

Country	Name	City	State
Norway	Physiology lab. Aker hospital, Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Mode Sensors AS	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in extracellular resistance of the calf from t0 to t1 (immediately before and after 40 minutes of LBNP at 30 mmHg), measured by the investigational bioimpedance device	Relative change in extracellular resistance at the calf from before to after 40 minutes of lower body negative pressure, to assess the effect of prolonged LBNP.	40 minutes
Secondary	Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device.	Relative change in extracellular resistance at the upper back following changes in posture	6 hours
Secondary	Changes in extracellular resistance at the upper back following application of three different external pressures.	Mean differences in extracellular resistance of the upper back, when the subject lays in a supine position on three different surfaces. Extracellular resistance is measured by the investigational bioimpedance device.	2 hours
Secondary	Frequency and severity of adverse device effects	To assess the safety of the investigational device in healthy volunteers	3 days