Testing of an Electronic Patch During Mild Dehydration

Overview

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.

Full Title of Study: “Testing of an Electronic Patch During Dehydration in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 3, 2023

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.).

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mode Sensors AS
  • Collaborator
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sigve N Aas, PhD, Study Director, Mode Sensors AS

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