Testing of an Electronic Patch During Mild Dehydration

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake. The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).

Official Title
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Testing of an Electronic Patch During Dehydration in Healthy Volunteers

Conditions
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Dehydration

Intervention / Treatment
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* Drug: Dehydration
* Dietary Supplement: Rehydration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: 18-30 Age: 18-60 Willing to refrain from exercise for the duration of the study Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing) Exclusion Criteria: Hypersensitivity to diuretics Diarrhea Hypotension or orthostatic hypotension Urinary retention Pregnancy or breast feeding Allergy to medical adhesive or gel Any planned medical examination during the intervention period Pacemaker Use of medication with a significant impact on the body's fluid balance, such as diuretic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open-labeled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydration sensor<br>The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3. | Drug: Dehydration<br>* 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.<br>* Other names: Dehydration from Furosemide;Dietary Supplement: Rehydration<br>* The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.<br>* Other names: Rehydration by Resorb Sport;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dehydration, Rehydration