Not Yet RecruitingPhase 2

Effectiveness of a Wearable Hydration Device

150 participantsStarted 2025-04-01

Plain-language summary

Dehydration among older adults a costs billions of dollars in US healthcare every year because no robust solution exists to detect changes in hydration and prevent negative outcomes. In this project, TritonX Technologies Inc. and academic research partners plan to test whether a newly created wearable sensor that measures hydration in real time can promote hydration and prevent the dehydration illnesses. The investigators will conduct a randomized controlled trial to examine the effectiveness of continuous home monitoring of fluid levels in a cohort of vulnerable older adult patients seen in the emergency care setting. The goal of this randomized control trial is to examine the effectiveness of continuous home monitoring of fluid levels in older patients presenting to the emergency department for dehydration. The main questions it aims to answer: 1. Can a wearable device accurately determine the severity of dehydration at home and 2. can a wearable device and continuous feedback from the device change behavior in the outpatient setting that can lead to improved outcomes in the treatment of dehydration in the elderly? Investigators will compare device readings, hydration diaries, vital signs, blood samples, return visits to the emergency department, and to see if feedback from the device decreases signs and symptoms of dehydration and changes home management of dehydration. Participants will be asked to: * wear the device and monitor hydration status * record the amount of home hydration * return in 7-10 days for reassessment of dehydration The successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA 510(k) and related regulatory processes and substantial enhancements to both our knowledge of older adult needs and device functionality.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adult patients aged 55 and over * rresenting to the emergency department * clinical suspicion of dehydration * treatment of dehydration/syncope with fluid resuscitation * English speaking Exclusion Criteria: * Refusal or inability to give informed consent, * severe clinical symptom requiring escalation of care beyond fluid resuscitation (ex. vasopressors, invasive blood pressure monitoring) * presumed/confirmed diagnosis of syncope secondary to a non-dehydration cause (ex. arrhythmia, stroke, pulmonary embolism, sepsis, valvular heart disease) * inability to lay flat for the test * body weight greater than 350 lbs * inability to fit measurement devices around the participant wrist * abnormal bodily fluid retention (lymphedema, ascites, pleural effusions, peripheral edema) * neuromotor disorders * current congestive heart failure exacerbation or heart attack/myocardial infarction * any implantable electronic devices * skin on limbs in poor condition (excessively, dry or rough or abrasions or wounds that would preclude application of electrode adhesive)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average daily fluid intake in mL

Timeframe: 10 days

Trial details

NCT IDNCT06788795

SponsorMetroHealth Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Joseph S Piktel, MD

216-778-2864 jpiktel@metrohealth.org

View on ClinicalTrials.gov More Dehydration trials