Testing of an Electronic Patch During Mild Dehydration

Testing of an Electronic Patch During Dehydration in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Dehydration
• Intervention / Treatment: Drug: Dehydration; Dietary supplement: Rehydration

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hydration sensor; The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.

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.; Other Names: Dehydration from Furosemide; 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.; Other Names: Rehydration by Resorb Sport

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mode Sensors AS
• Collaborators: Oslo University Hospital
• Investigators: Study Director: Sigve N Aas, PhD, Mode Sensors AS

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dehydration; Rehydration
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: CTR041 REO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing planned. Application to ethical board does not include permission to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No