Effectiveness of a Wearable Hydration Device

NCT06788795 | Not Yet Recruiting Phase 2

• 2 other identifiers: STUDY00000196R42AG080886
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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

Keywords

dehydration; total body water; bioimpedence; emergency department

Outcome Measures

Primary Outcomes (1)

• Average daily fluid intake in mL

  The average daily fluid intake over 10 days as determined by a standardized Drink Diary

  10 days

Secondary Outcomes (10)

• Level of total body water after 10 days

  10 days

• Midpoint Clinical symptoms of dehydration

  5 days

• End of Study Report of Dehydration

  10 days

• End of Study Visit Heart Rate (beats per minute)

  10 days

• End of Study Visit Blood Pressure

  10 days

Study Arms (2)

Device with Interactive Phone App

ACTIVE COMPARATOR

In this arm, patients will receive the wearable dehydration device and receive the phone app, which will include prompts to check their dehydration status and to drink more fluids if necessary

Device: Device with Phone App

Device without Interactive Phone APp

SHAM COMPARATOR

In this arm, patients will receive the wearable dehydration device without the phone app

Device: Device without Phone App

Interventions

Device with Phone App DEVICE

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

Device with Interactive Phone App

Device without Phone App DEVICE

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

Device without Interactive Phone APp

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged 55 and over
• rresenting to the emergency department
• clinical suspicion of dehydration
• treatment of dehydration/syncope with fluid resuscitation
• English speaking

You may not qualify if:

• 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)

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Dehydration; Syncope; Emergencies

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Disease Attributes

Study Officials

• Jospeh S Piktel, MD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph S Piktel, MD

CONTACT

216-778-2864; jpiktel@metrohealth.org

Julie Nichols, RN

CONTACT

216-957-6488; jnichols@metrohealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Device and phones are identical but apps will either prompt or not prompt
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 23, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share