Testing of an Electronic Patch During Dehydration in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Dehydration
- Conditions
- Dehydration
- Sponsor
- Mode Sensors AS
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change in impedance following mild dehydration
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.).
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
Hydration sensor
The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.
Intervention: Dehydration
Hydration sensor
The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.
Intervention: Rehydration
Outcomes
Primary Outcomes
Change in impedance following mild dehydration
Time Frame: 2 hours
Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days
Secondary Outcomes
- Change in impedance following rehydration(1 hour)