NCT05129358

Testing of an Electronic Patch During Mild Dehydration

Testing of an Electronic Patch During Dehydration in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Mode Sensors AS · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.).

Conditions

• Dehydration

Interventions

Type	Name	Description
DRUG	Dehydration	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.
DIETARY_SUPPLEMENT	Rehydration	The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.

Timeline

• Start date: 2022-05-30
• Primary completion: 2023-11-03
• Completion: 2023-11-03
• First posted: 2021-11-22
• Last updated: 2023-12-20

Locations

1 site across 1 country: Norway