Testing of an Electronic Patch During Mild Dehydration

Dehydration Clinical Trial

Official title:

Testing of an Electronic Patch During Dehydration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129358
• Other study ID #: CTR041 REO
• Status: Completed
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: November 3, 2023

Study information

• Verified date: December 2023
• Source: Mode Sensors AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Mode Sensors AS	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in impedance following rehydration	Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé)	1 hour