30 Participants NeededMy employer runs this trial

Wearable Photoplethysmography for Dehydration

Recruiting at 1 trial location
AW
Overseen ByAnthony Wolfe
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a wearable device can measure hydration by analyzing blood flow just under the skin. Instead of traditional methods like checking body mass or urine, the study uses light sensors on the device to detect changes in blood volume, which might indicate hydration levels. Participants will be divided into two groups: one will stay hydrated, and the other will limit fluids to test the device's accuracy. Those who frequently exercise and are willing to wear a wrist device while following specific guidelines, such as fasting overnight, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could revolutionize hydration monitoring.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you cannot take medications that might interfere with the study. It's best to discuss your current medications with the study team to see if they are allowed.

What prior data suggests that this wearable device is safe for monitoring hydration?

Research has shown that wearable devices using light sensors, known as PPG, are generally easy for people to use. In a study with 240 participants, researchers tested a wearable hydration sensor using PPG and other technologies. They carefully monitored participants to ensure they did not lose too much water, emphasizing a focus on safety. The study reported no serious side effects, indicating these devices are safe for everyday use.

PPG sensors, found in many wearable health gadgets, often track heart rate and blood flow. They are noninvasive, meaning they don't need to break the skin or enter the body, which reduces the risk of complications. While research continues to improve these devices for monitoring hydration, current evidence supports their safety for general use.12345

Why are researchers excited about this trial?

Researchers are excited about wearable photoplethysmography for dehydration because it offers a non-invasive way to monitor hydration levels in real-time, unlike traditional methods that rely on blood tests or urine analysis. This technology uses light to measure changes in blood volume under the skin, providing immediate feedback. This could revolutionize how dehydration is detected and managed, especially in athletes or individuals in demanding environments, by offering continuous, on-the-go monitoring without the need for lab tests.

What evidence suggests that this wearable photoplethysmography device is effective for monitoring hydration?

This trial will compare the effectiveness of wearable photoplethysmography (PPG) in monitoring hydration levels between two groups: the Euhydrated Group, where water compensates for sweat loss during exercise, and the Dehydrated Group, where fluid is restricted. Research has shown that wearable devices can monitor hydration using PPG technology, which shines light through the skin to assess blood flow and indicate hydration levels. In a study with 240 participants, these devices accurately tracked hydration changes using PPG and other sensors. Another study found that combining PPG with machine learning enhanced hydration monitoring. Although no wrist-worn device can perfectly predict hydration yet, early results for this method are promising.13567

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 who are healthy, can read and write English, are willing to fast overnight, avoid alcohol and vigorous exercise before visits, eat the same food before each visit, wear a wrist device during the study, and undergo temporary fluid restriction. Pregnant or breastfeeding women and those with health issues affected by dehydration cannot join.

Inclusion Criteria

Subject is willing to fast overnight (no food or beverage, only water, ~8- 10 hours)
Subject is willing to refrain from vigorous exercise for 24 hours
Subject is willing to eat the exact same food the day prior to each visit to the testing site
See 10 more

Exclusion Criteria

I have a condition or take medication that could get worse if I limit my fluid intake.
Subject has participated or currently enrolled in a clinical trial within the past 30 days
Subject has participated in any PepsiCo trial within the past 3 months
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Baseline measurements including heart rate, blood pressure, and subject demographics are collected

1 day
1 visit (in-person)

Exercise and Hydration Monitoring

Participants undergo exercise sessions with continuous monitoring of hydration status using wearable devices

2 days
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the exercise and hydration monitoring phase

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Wearable Photoplethysmography

Trial Overview

The study tests if a wearable device using light sensors (photoplethysmography) worn on the wrist can accurately measure hydration levels in people while they exercise. Participants will have their hydration monitored non-invasively using this technology.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Euhydrated GroupExperimental Treatment1 Intervention
Group II: Dehydrated GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials
99
Recruited
13,600+

Ramon Laguarta

PepsiCo Global R&D

Chief Executive Officer since 2018

MBA from ESADE Business School

Mark Kirkham

PepsiCo Global R&D

Chief Marketing Officer

Bachelor's degree in Business Administration from Trinity College Dublin

Citations

Recent Advancements in Wearable Hydration-Monitoring ...

This review comprehensively examined recent advancements in wearable hydration-monitoring technologies, focusing on their capabilities, limitations, and ...

Effectiveness of a Wearable Hydration Device (DRINK)

The successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA ...

An accurate wearable hydration sensor: Real-world ... - PMC

A wearable body hydration sensor employing photoplethysmographic and galvanic biosensors was field evaluated using 240 human participants with equal numbers ...

Towards Data-Driven Hydration Monitoring: Insights from ...

Outcomes of interest include the accuracy of monitoring methods, efficacy of sensors, ML performance metrics (e.g., accuracy, sensitivity), and ...

An accurate wearable hydration sensor: Real-world ...

A wearable body hydration sensor employing photoplethysmographic and galvanic biosensors was field evaluated using 240 human participants.

Towards On-Device Dehydration Monitoring Using ...

In this paper, we address the use of machine learning for hydration monitoring using data from wearable sensors.

Systematic literature review of wearable devices and data ...

This systematic review aims to provide a holistic exploration of the construction safety and health literature to identify application areas and challenges