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Completed

NCT Number: NCT05129358

Testing of an Electronic Patch During Mild Dehydration

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.

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Key information

Conditions

Dehydration Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dehydration

Drug

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

Rehydration

Dietary Supplement

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

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Mode Sensors AS

Industry

Collaborators

  • Oslo University Hospital

Registry information

Official study title

Testing of an Electronic Patch During Dehydration in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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