Contributing Factors to Local Bioimpedance Spectroscopy (NCT06003205) | Clinical Trial Compass
CompletedNot Applicable
Contributing Factors to Local Bioimpedance Spectroscopy
Norway11 participantsStarted 2023-09-04
Plain-language 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).
Who can participate
Age range18 Years – 50 Years
SexALL
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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 precipitati…
What they're measuring
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