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Real-time microwearable sensor for monitoring human hydration status

Diagnostic performance of real-time microwearable sensor for monitoring hydration status in healthy volunteers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000230651
Enrollment
45
Registered
2023-03-03
Start date
2023-03-21
Completion date
2024-07-03
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

WearOptimo is developing the MicrowearableTM Hydration Sensor (the Microwearable) that utilizes localized impedance measurements to monitor, in real-time, changes in hydration. The Microwearable has been designed on the hypothesis that mild, systemic dehydration can be detected through changes in the impedance characteristics of the skin. By passing a small alternating current between microneedles that have been painlessly inserted into the uppermost layers of the skin, detection and notification of dehydration status can be provided to the Microwearable user. This study will be the first in-human study of the WearOptimo Microwearable Hydration Sensor. A key question for the feasibility of the Microwearable is whether dehydration at the systemic level will produce a corresponding pattern of changes in skin impedance that is consistent enough to support dehydration detection and diagnosis, against the background of natural confounding processes (sweat, motion, heart rate, blood pressure and local skin temperature changes). To monitor contrasting levels of hydration, each participant will attend two trials with intervals of light exercise: • Exercise in a hot and dry environment with continuous fluid replacement; • Restriction of fluids for 24-hours followed by exercising in a hot and dry environment. The primary endpoint will be the diagnostic performance of the Microwearable for detection of the dehydrated state. Diagnostic performance will be evaluated with sensitivity and specificity of detection of the dehydrated state determined by receiver operating characteristic (ROC) analysis of a binary classification distinguishing euhydrated and dehydrated states.

Interventions

Fluid restriction followed by exercise-induced dehydration The first visit (less than one hour) will involve several measures of hydration status (including body weight, a small quantity of blood collected via venipuncture in the arm and urine samples). You will then go about your normal daily activities for the next 24 hours but will be requested to minimise fluid intake. The following dietitian guided information will be provided: In the 24 hours leading up to your exercise session, please

Fluid restriction followed by exercise-induced dehydration The first visit (less than one hour) will involve several measures of hydration status (including body weight, a small quantity of blood collected via venipuncture in the arm and urine samples). You will then go about your normal daily activities for the next 24 hours but will be requested to minimise fluid intake. The following dietitian guided information will be provided: In the 24 hours leading up to your exercise session, please minimise: - drinks & liquids e.g. water, coffee, tea, soft drink, sports drinks, milk, juice, alcohol - fluids that are part of a food e.g. soup, sauces, gravies, pudding, yoghurt, salad dressing - foods that will melt down to a liquid e.g. ice cream, frozen yoghurt, milkshakes/smoothies, ice blocks, ice cubes - juicy fruits or vegetables e.g. melons (watermelon, rockmelon,honeydew, etc.), berries (strawberries, blueberries, raspberries, blackberries, etc.), tomatoes, cucumbers To reduce thirst and alleviate dry mouth: - eat a low salt diet (salty foods will increase your thirst) - keep hard candies, mints and gum available. some people find sugar-freevarieties to be more thirst quenching - brush your teeth - chill mouthwash and gargle for a fresh feeling - rinse your mouth with water (no swallowing). - add lemon or cucumber to your water to help quench your thirst. - freeze or partially freeze pieces of fruit for a refreshing treat: like lemon wedges, orange sections, peaches, berries, or grapes - breathe through your nose and not your mouth - avoid mid-day heat The second and final visit (24 hours following the first) will involve exposure to a hot and dry environment (40 deg C and 20% relative humidity). You will walk at 5 km.h-1 and 1% gradient for 150 minutes. This will be conducted in five 30 minutes bouts, separated by 20 minutes rest. Before, during, and after this session several measures of hydration status (including changes in body weight, blood and urine samples) will be recorded during the rest periods. Nude body weight will be conducted alone in a lockable room. Blood samples (six by 6-ml collections) will be collected from a cannula inserted, by a trained phlebotomist, into the antecubital fossa of the elbow. The blood will be assessed for osmolality, a hydration marker, at each time point. Baseline urine samples will be assessed for specific gravity and colour. Heart rate, core and skin temperature will be recorded continuously. Heart rate will be measured with a chest strap and watch, core temperature via a rectal probe and skin temperature with four wireless sensors (approximately 1cm in diameter) placed on the surface of the skin. This session will be overseen by an exercise scientist and/or exercise physiologist accredited with Exercise and Sport Science Australia (ESSA). The hydration MicrowearableTM sensor will also be worn continuously throughout this second visit. The MicrowearableTM is a disposable single-use device, developed by WearOptimo, it comprises an array of microelectrode-projections that upon application to skin, will penetrate the upper most layer of the skin. The sensor may be placed on the following locations: shoulder, sternum, and hand. Bioimpedance spectroscopy (BIS), which has been developed as a measure of body composition and fluid volume status, is used to continuously measure skin tissue composition between the microelectrode-projections. The washout period prior to undertaking the alternative condition will be at least 7 days.

Sponsors

WearOptimo
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

To be eligible for study entry participants must satisfy all of the following criteria: 1. Male or female over 18 years of age, inclusive at the time of screening; 2. Generally healthy and considered to be of ‘Low Risk’ for suffering from an adverse event during physical activity per the Exercise and Sports Science Australia (ESSA) adult pre-exercise screening tool; 3. Partake on average in greater than or equal to 150-minutes weighted physical activity per week; with an emphasis on endurance exercise; 4. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.

Exclusion criteria

Participants will be excluded from the study if one or more of the following criteria are applicable: 1. Have an implanted pacemaker or cardiogenic device; 2. Have a known skin allergy to gold; 3. Has any known blood clotting disorders (e.g., hemophilia), or taking any blood thinning medications or have any red blood cell disorders (e.g., thalassemia) (due to the requirement for blood collection during the study); 4. Women who are pregnant or breast feeding; 5. Identified as ‘Higher Risk Participants’ (i.e., answered ‘Yes’ to any of the Stage 1 questions via the ESSA adult pre-exercise screening tool); 6. Concurrently participating in any other clinical study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026