Contributing Factors to Local Bioimpedance Spectroscopy (COBI)

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

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).

Study Overview

• Status: Completed
• Conditions: Edema; Fluid and Electrolyte Imbalance; Overhydration
• Intervention / Treatment: Device: Wearable bioimpedance sensor

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigve N Aas, PhD; Phone Number: 004741499074; Email: sigve.aas@modesensors.com
• Study Contact Backup: Name: Frida Bremnes, M.Sc.; Email: frida.bremnes@modesensors.com

Study Locations

• Norway
  • Oslo, Norway, 0586
    • Physiology lab. Aker hospital, Oslo University Hospital
    • Contact: Lars Ø Høiseth, PhD; Email: LHOIS@ous-hf.no
    • Principal Investigator: Lars Ø Høiseth, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Wearable bioimpedance sensor; All subjects will use the investigational device and undergo several interventions: lower body negative pressure (3-40 minutes at 30 mmHg), posture intervention, and pressure 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Frequency and severity of adverse device effects	To assess the safety of the investigational device in healthy volunteers	3 days

Collaborators and Investigators

• Sponsor: Mode Sensors AS
• Collaborators: Oslo University Hospital
• Investigators: Study Director: Sigve N Aas, PhD, Mode Sensors AS; Principal Investigator: Lars Ø Høiseth, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hydration
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Metabolic Diseases; Water-Electrolyte Imbalance; Poisoning; Water Intoxication
• Other Study ID Numbers: DOC1040A COBI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No