Testing of an Electronic Patch During Mild Dehydration

NCT05129358 | Completed DMC

• 1 other identifier: CTR041 REO
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dehydration

Keywords

Dehydration; Rehydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in impedance following rehydration

  1 hour

Study Arms (1)

Hydration sensor

EXPERIMENTAL

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

Drug: Dehydration; Dietary Supplement: Rehydration

Interventions

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.

Also known as: Dehydration from Furosemide

Hydration sensor

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.

Also known as: Rehydration by Resorb Sport

Hydration sensor

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mode Sensors AS: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Noddeland H, Bremnes F, Thorud A, Rolid K, Kvaerness J, Jaatun EA, Aas SN. A novel wearable bioimpedance sensor for continuous monitoring of fluid balance: a study on isotonic hypovolemia in healthy adults. J Clin Monit Comput. 2025 Apr;39(2):379-391. doi: 10.1007/s10877-024-01245-z. Epub 2024 Dec 4.

  PMID: 39630397 DERIVED

MeSH Terms

Conditions

Dehydration

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Sigve N Aas, PhD

  Mode Sensors AS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-labeled

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 22, 2021
• Study Start: May 30, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)