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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.
The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydration sensor | Experimental | The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dehydration | Drug | The subject is brought to mild dehydration (loss of approximately 1.5% of body weight) through intravenous injection of up to 40 ug Furosemide. The subject shall not ingest any fluid for the next 120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in impedance following mild dehydration | Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in impedance following rehydration | Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé) | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigve N Aas, PhD | Mode Sensors AS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39630397 | Derived | Noddeland H, Bremnes F, Thorud A, Rolid K, Kvaerness J, Jaatun EA, Aas SN. A novel wearable bioimpedance sensor for continuous monitoring of fluid balance: a study on isotonic hypovolemia in healthy adults. J Clin Monit Comput. 2025 Apr;39(2):379-391. doi: 10.1007/s10877-024-01245-z. Epub 2024 Dec 4. |
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No sharing planned. Application to ethical board does not include permission to share.
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Open-labeled
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| Rehydration | Dietary Supplement | The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake. |
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| D013568 | Pathological Conditions, Signs and Symptoms |