Clinical trial NCT06003205: Contributing Factors to Local Bioimpedance Spectroscopy
Official title: Assessment of Contributing Factors to Local Bioimpedance Spectroscopy Using a Wearable Sensor: An Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid and Electrolyte Imbalance
Overhydration
Edema
Keywords: Hydration
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: Oslo University Hospital
First posted: 2023-08-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: 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
timeFrame: 40 minutes
Secondary outcomes:
measure: Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device.
timeFrame: 6 hours
measure: Changes in extracellular resistance at the upper back following application of three different external pressures.
timeFrame: 2 hours
measure: Frequency and severity of adverse device effects
timeFrame: 3 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Physiology lab. Aker hospital, Oslo University Hospital
Study officials:
affiliation: Mode Sensors AS
name: Sigve N Aas, PhD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Lars Ø Høiseth, PhD
role: PRINCIPAL_INVESTIGATOR
References: