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Testing of an Electronic Patch During Mild Dehydration

NCT ID: NCT05129358

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2023-11-03

Brief Summary

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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

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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.).

Conditions

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Dehydration

Keywords

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Dehydration Rehydration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-labeled
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hydration sensor

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

Group Type EXPERIMENTAL

Dehydration

Intervention Type 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.

Rehydration

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Rehydration

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dehydration from Furosemide Rehydration by Resorb Sport

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Mode Sensors AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sigve N Aas, PhD

Role: STUDY_DIRECTOR

Mode Sensors AS

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 39630397 (View on PubMed)

Other Identifiers

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CTR041 REO

Identifier Type: -

Identifier Source: org_study_id