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Testing of an Electronic Patch During Mild Dehydration

Primary Purpose

Dehydration

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Dehydration

Rehydration

About this trial

This is an interventional other trial for Dehydration focused on measuring Dehydration, Rehydration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Up to 40 healthy volunteers,
physically trained test subjects.
must be able to perform a workout at 80% of maximum heart rate for 60 minutes according to Nes et al. [1],
OR perform a workout that causes a dehydration of more than 1.5% of total body weight.

Exclusion Criteria:

Hypersensitivity to sulfonamide or thiazide diuretics.
Acid/base imbalance
Electrolyte imbalance
Metabolic alkalosis
Diarrhea
Hypotension or orthostatic hypotension
Prostatic hypertrophy, urethral stricture, urinary retention
Pregnancy or breast feeding
Allergy to medical adhesive or gel.
Any planned medical examination during the intervention period.

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydration sensor

Arm Description

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

Outcomes

Primary Outcome Measures

Change in impedance following mild dehydration

Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days

Secondary Outcome Measures

Change in impedance following rehydration

Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé)

Full Information

NCT ID

NCT05129358

First Posted

October 29, 2021

Last Updated

August 10, 2023

Sponsor

Mode Sensors AS

Collaborators

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05129358

Brief Title

Testing of an Electronic Patch During Mild Dehydration

Official Title

Testing of an Electronic Patch During Dehydration in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 30, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mode Sensors AS

Collaborators

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dehydration

Keywords

Dehydration, Rehydration

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open-labeled

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydration sensor

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dehydration

Other Intervention Name(s)

Dehydration from Furosemide

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Rehydration

Other Intervention Name(s)

Rehydration by Resorb Sport

Intervention Description

The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.

Primary Outcome Measure Information:

Title

Change in impedance following mild dehydration

Description

Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Change in impedance following rehydration

Description

Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé)

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sigve N Aas, PhD

Phone

+4741499074

sigve.aas@modesensors.com

First Name & Middle Initial & Last Name or Official Title & Degree

Frida Bremnes, M.Sc.

frida.bremnes@modesensors.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sigve N Aas, PhD

Organizational Affiliation

Mode Sensors AS

Official's Role

Study Director

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harald Noddeland, MD PhD

Phone

+4797402040

harnod@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Leiv A Rosseland, MD PhD

Phone

+4791502770

Ext

lrossela@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Harald Noddeland, MD PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No sharing planned. Application to ethical board does not include permission to share.

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Testing of an Electronic Patch During Mild Dehydration

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