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Testing of an Electronic Patch During Mild Dehydration

M

Mode Sensors

Status

Completed

Conditions

Dehydration

Treatments

Drug: Dehydration
Dietary Supplement: Rehydration

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05129358
CTR041 REO

Details and patient eligibility

About

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 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.).

Enrollment

31 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Hydration sensor
Experimental group
Description:
The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.
Treatment:
Drug: Dehydration
Dietary Supplement: Rehydration

Trial contacts and locations

1

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Central trial contact

Sigve N Aas, PhD; Frida Bremnes, M.Sc.

Data sourced from clinicaltrials.gov

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