Contributing Factors to Local Bioimpedance Spectroscopy

NCT ID: NCT06003205

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2023-09-14

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.

Conditions

Fluid and Electrolyte Imbalance; Overhydration; Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Wearable bioimpedance sensor

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Mode Sensors AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigve N Aas, PhD

Role: STUDY_DIRECTOR

Mode Sensors AS

Lars Ø Høiseth, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Physiology lab. Aker hospital, Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

DOC1040A COBI

Identifier Type: -

Identifier Source: org_study_id