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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device. | Relative change in extracellular resistance at the upper back following changes in posture | 6 hours |
| Changes in extracellular resistance at the upper back following application of three different external pressures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigve N Aas, PhD | Mode Sensors AS | Study Director |
| Lars Ø Høiseth, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiology lab. Aker hospital, Oslo University Hospital | Oslo | 0586 | Norway |
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| ID | Term |
|---|---|
| D014869 | Water Intoxication |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011041 | Poisoning |
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Mean differences in extracellular resistance of the upper back, when the subject lays in a supine position on three different surfaces. Extracellular resistance is measured by the investigational bioimpedance device. |
| 2 hours |
| Frequency and severity of adverse device effects | To assess the safety of the investigational device in healthy volunteers | 3 days |
| D064419 | Chemically-Induced Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |