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Contributing Factors to Local Bioimpedance Spectroscopy (COBI)

Primary Purpose

Fluid and Electrolyte Imbalance, Overhydration, Edema

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Wearable bioimpedance sensor
Sponsored by
Mode Sensors AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fluid and Electrolyte Imbalance focused on measuring Hydration

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Physiology lab. Aker hospital, Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Wearable bioimpedance sensor

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Frequency and severity of adverse device effects
To assess the safety of the investigational device in healthy volunteers

Full Information

First Posted
August 2, 2023
Last Updated
September 19, 2023
Sponsor
Mode Sensors AS
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06003205
Brief Title
Contributing Factors to Local Bioimpedance Spectroscopy
Acronym
COBI
Official Title
Assessment of Contributing Factors to Local Bioimpedance Spectroscopy Using a Wearable Sensor: An Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mode Sensors AS
Collaborators
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid and Electrolyte Imbalance, Overhydration, Edema
Keywords
Hydration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable bioimpedance sensor
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wearable bioimpedance sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device.
Description
Relative change in extracellular resistance at the upper back following changes in posture
Time Frame
6 hours
Title
Changes in extracellular resistance at the upper back following application of three different external pressures.
Description
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.
Time Frame
2 hours
Title
Frequency and severity of adverse device effects
Description
To assess the safety of the investigational device in healthy volunteers
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigve N Aas, PhD
Organizational Affiliation
Mode Sensors AS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lars Ø Høiseth, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiology lab. Aker hospital, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0586
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Contributing Factors to Local Bioimpedance Spectroscopy

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