Effectiveness of a Wearable Hydration Device

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.

Conditions

• Dehydration
• Syncope and Collapse

Interventions

DEVICE

Device with Phone App

This is the intervention where the patients will be given both the wearable dehydration device as well as the phone app

DEVICE

Device without Phone App

This is the intervention where the patients will receive the device alone

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• MetroHealth Medical Center

  lead OTHER

Principal Investigators

• Jospeh S Piktel, MD · MetroHealth System, Ohio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2026-07-01

Completion

2026-12-31