SBIR-STTR Award

Clinical Effectiveness of a Wearable Hydration Device
Award last edited on: 2/14/2024

Sponsored Program
STTR
Awarding Agency
NIH : NIA
Total Award Amount
$314,539
Award Phase
1
Solicitation Topic Code
866
Principal Investigator
Eamon Johnson

Company Information

Tritonx Inc

5009 N Hermitage Avenue # 2
Chicago, IL 60640
   (773) 841-9613
   N/A
   www.tritonx.co

Research Institution

Case Western Reserve University

Phase I

Contract Number: 1R42AG080886-01
Start Date: 9/30/2022    Completed: 8/31/2023
Phase I year
2022
Phase I Amount
$259,939
Dehydration among older adults costs billions of US healthcare dollars every year. While not always the primary focus of care, dehydration is a pervasive comorbidity in hospitalizations and deaths of older adult patients. Dehydration is of vital importance, especially among vulnerable older adults because: (1) Older persons can have additional difficulty monitoring their own fluid intake (2) existing technologies do not present a consistent, actionable mechanism for measuring dehydration in home settings and other areas where older adults live independently. Hydration measurement techniques available to care providers today are either inconsistent, laborious, inaccurate, or not feasible. Dehydration is an ambulatory-care-sensitive condition and is preventable and reversible. Health care outcomes can be improved and hospital expenditures reduced or prevented through home monitoring of hydation, changes in health behaviors of older adults and the rendering prompt, appropriate care. TritonX has created a wearable sensor based on bioimpedance spectroscopy (BIS) techniques to measure personal hydration in real time with sufficient accuracy to assess significant fluid changes in the human body. Our value proposition is to track the changes in the body fluids in real time and to alert the caretakers/patient if the hydration level of the patient falls below a certain threshold. In this STTR Fast Track Application we propose to, in Phase 1, determine the ideal user experience, device settings and health care communication needs when conducting continuous monitoring of fluid levels among older adults in their homes. In Phase 2, we 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 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.

Public Health Relevance Statement:
Project Narrative 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.

Project Terms:
Achievement; Achievement Attainment; Adult; 21+ years old; Adult Human; adulthood; Affect; Aftercare; After Care; After-Treatment; post treatment; Elderly; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Ambulatory Care; Outpatient Care; outpatient treatment; Body Composition; Body Fluids; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Clinical Trials; Communication; comorbidity; co-morbid; co-morbidity; Cessation of life; Death; Decision Making; Dehydration; body water dehydration; Dialysis procedure; Dialysis; dialysis therapy; Disease; Disorder; Water consumption; Water Intake; Expenditure; Extracellular Fluid; Health; Health behavior; health related behavior; Health Status; Level of Health; Congestive Heart Failure; Cardiac Failure Congestive; Heart Decompensation; chronic heart failure; Hospitalization; Hospital Admission; Hospitals; Hypernatremia; Hypotension; Low Blood Pressure; Vascular Hypotensive Disorder; Intracellular Fluid; Laboratories; Morbidity - disease rate; Morbidity; mortality; Patients; Research; Risk; Self-Administered; Self Administration; Na element; Sodium; Spectroscopy; Spectrum Analyses; Spectrum Analysis; Survival Rate; Fainting; Syncope; Technology; Testing; Time; Work; Wrist; Measures; falls; Healthcare; health care; Caring; base; sensor; improved; Body measure procedure; Body Measures; Area; Acute; Clinical; Phase; Neurologic; Neurological; Hospital Costs; Hospitalization cost; Recovery; Measurement; Sample Size; Fluid Shifts; Human Figure; Human body; randomized control trial; Randomized Controlled Trials; fluid; liquid; Liquid substance; lightweight; light weight; Knowledge; Complex; Event; Techniques; Organ System; body system; Outcome Study; Emergency Department; Emergency room; Accident and Emergency department; acute kidney injury; Acute Renal Failure with Renal Papillary Necrosis; experience; monitoring device; cohort; Preventative strategy; Preventive strategy; Prevention strategy; Devices; Reporting; Vulnerable Populations; vulnerable group; vulnerable people; Effectiveness; preventing; prevent; Hydration; Hydration status; telehealth; Data; Intake; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; Small Business Technology Transfer Research; STTR; Monitor; Process; Emergency Care; ED care; ER care; Emergency Department care; Emergency Room care; Emergency healthcare; Emergency medical care; Emergency health care; cost; time use; novel strategies; new approaches; novel approaches; novel strategy; Clinical effectiveness; Outcome; Population; temporal measurement; temporal resolution; time measurement; Data Science; wearable sensor technology; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable system; care providers; primary care provider; care outcomes; health care outcomes; healthcare outcomes; acute care; Home

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
$54,600