Contributing Factors to Local Bioimpedance Spectroscopy (COBI)
Fluid and Electrolyte Imbalance, Overhydration, Edema
About this trial
This is an interventional basic science trial for Fluid and Electrolyte Imbalance focused on measuring Hydration
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.
Sites / Locations
- Physiology lab. Aker hospital, Oslo University Hospital
Arms of the Study
Arm 1
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.