Testing of an Electronic Patch During Mild Dehydration

Not Applicable

Completed

• Conditions: Dehydration
• Interventions: Drug: Dehydration; Dietary Supplement: Rehydration

• Registration Number: NCT05129358
• Lead Sponsor: Mode Sensors AS

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.).

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Start: 2022-05-30
• Primary Completion: 2023-11-03
• Study Completion: 2023-11-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydration sensor	Rehydration	The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.
Hydration sensor	Dehydration	The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.

Primary Outcome Measures

Name	Time	Method
Change in impedance following mild dehydration	2 hours	Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days

Secondary Outcome Measures

Name	Time	Method
Change in impedance following rehydration	1 hour	Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé)

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway