Contributing Factors to Local Bioimpedance Spectroscopy

NCT06003205 | Completed

• 1 other identifier: DOC1040A COBI
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Fluid and Electrolyte Imbalance; Overhydration; Edema

Keywords

Hydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device.

  6 hours

• Changes in extracellular resistance at the upper back following application of three different external pressures.

  2 hours

• Frequency and severity of adverse device effects

  3 days

Study Arms (1)

Wearable bioimpedance sensor

OTHER

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

Interventions

Wearable bioimpedance sensor 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.

Wearable bioimpedance sensor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mode Sensors AS: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Physiology lab. Aker hospital, Oslo University Hospital

Oslo, 0586, Norway

Location

MeSH Terms

Conditions

Water Intoxication; Edema

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigve N Aas, PhD

  Mode Sensors AS

  STUDY DIRECTOR

• Lars Ø Høiseth, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 21, 2023
• Study Start: September 4, 2023
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)