Loading clinical trials...

COMPLETEDNA

Contributing Factors to Local Bioimpedance Spectroscopy

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

NCT06003205•Mode Sensors AS

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Physiology lab. Aker hospital, Oslo University Hospital

Oslo, Norway

Key Dates

Start Date

September 4, 2023

Primary Completion Date

September 14, 2023

Completion Date

September 14, 2023

Last Updated

March 12, 2024

Enrollment

ACTUAL participants

Conditions

Fluid and Electrolyte ImbalanceOverhydrationEdema

Interventions

Wearable bioimpedance sensor

DEVICE

Volume Kinetics of Fluid Resuscitation in Early Sepsis

NCT06499701

Fluid and Electrolyte Imbalance

View study

RECRUITINGPHASE3

Donidalorsen Treatment in Children With Hereditary Angioedema

NCT07298447

Hereditary Angioedema (HAE)

View study

RECRUITINGPHASE3

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Contributing Factors to Local Bioimpedance Spectroscopy

Inclusion Criteria

Exclusion Criteria

Volume Kinetics of Fluid Resuscitation in Early Sepsis

Donidalorsen Treatment in Children With Hereditary Angioedema

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

Heparin-binding Protein and Lungedema in ICU Patients.

Evaluation of Physical Activity in Women With Lipedema

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME