SBIR-STTR Award

Non-contact In-Bed Sensing of Heart Failure Decompensation
Award last edited on: 1/31/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$223,612
Award Phase
1
Solicitation Topic Code
837
Principal Investigator
Raymond C Chan

Company Information

Nightingale Labs Corporation

11921 Carmel Creek Road
San Diego, CA 92130
   (617) 869-9339
   N/A
   www.nightingalelabs.com
Location: Single
Congr. District: 52
County: San Diego

Phase I

Contract Number: 1R43HL157291-01
Start Date: 3/15/2021    Completed: 3/14/2022
Phase I year
2021
Phase I Amount
$223,612
Chronic heart failure is a highly prevalent and costly disease marked by frequent exacerbations leading to recurrent hospitalizations. Heart failure patients have extraordinarily high hospitalization rates for fluid overload, which can often be avoided if exacerbations are detected early and diuretic therapy is intensified in the outpatient setting. Unfortunately, self- measurement of weights and self-reporting of symptoms have proven ineffective. The utility of home monitoring technologies has been limited by poor adherence to self-measurement, self- transmission of data, or self-application of wearables. Implantable devices have shown success but are invasive and expensive. Non-contact sensors are currently position-dependent and not compatible with multiple persons sleeping in the same bed. Nightingale Labs was founded to commercialize a non-contact adherence-independent sensor called Bedscales. Our preliminary results show that the low-profile mechanical sensors, when placed beneath the legs of a home bed, can perform adherence-independent sensing of total body weight, movements, respirations, and cardiac signals for months without patient interaction, even if the bed is shared by partners or pets. The overall goal of this Phase I SBIR is to define sensor accuracy in a real- world heart failure population in preparation for a prospective clinical study in Phase 2. By defining the signatures of impending hospitalization, BedScales aims to make outpatient management of heart failure a data-driven science.

Public Health Relevance Statement:


Project narrative:
Heart failure is a high prevalent chronic disease of older adults that leads to fluid overload causing weight gain, shortness of breath, and arrhythmias. Existing sensors for managing heart failure in the outpatient setting are invasive, require self-measurement, or are not compatible with people who share a bed. BedScales is a non-contact sensor solves these problems and aims to improve the care of older adults with heart failure.

Project Terms:
Affect ; Age ; ages ; Elderly ; advanced age ; elders ; geriatric ; late life ; later life ; older adult ; older person ; senior citizen ; Algorithms ; Arrhythmia ; Cardiac Arrhythmia ; Heart Arrhythmias ; Breathing ; Respiratory Aspiration ; Respiratory Inspiration ; inspiration ; Atrial Fibrillation ; Auricular Fibrillation ; Back ; Dorsum ; Beds ; Body Weight ; Charge ; Chronic Disease ; Chronic Illness ; chronic disorder ; Clinic Visits ; Clinical Research ; Clinical Study ; Clinical Trials ; Data Reporting ; data representation ; Decision Making ; Disease ; Disorder ; Diuretics ; Family ; Fright ; Fear ; Feedback ; Patient Care ; Patient Care Delivery ; Goals ; Health ; Medicare ; Health Insurance for Aged and Disabled, Title 18 ; Health Insurance for Disabled Title 18 ; Title 18 ; health insurance for disabled ; Heart failure ; cardiac failure ; Congestive Heart Failure ; Cardiac Failure Congestive ; Heart Decompensation ; chronic heart failure ; Hospitalization ; Hospital Admission ; implantable device ; biomedical implant ; implant device ; indwelling device ; Lung ; Lung Respiratory System ; pulmonary ; Movement ; body movement ; Persons ; Outpatients ; Out-patients ; Patients ; Periodicity ; Cyclicity ; Rhythmicity ; pet animal ; pets ; Problem Solving ; Pulmonary artery structure ; Pulmonary Artery ; Recurrence ; Recurrent ; Respiration ; respiratory mechanism ; Science ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Sleep ; Tachycardia ; Technology ; Testing ; Time ; Ventricular Tachycardia ; Virus ; Weight Gain ; Weight Increase ; body weight gain ; body weight increase ; wt gain ; Weight ; Measures ; Caregivers ; Care Givers ; Health Care Costs ; Health Costs ; Healthcare Costs ; Healthcare ; health care ; Caring ; Custom ; Cost of Illness ; Disease Costs ; Sickness Cost ; sensor ; improved ; Clinical ; Phase ; Physiological ; Physiologic ; Measurement ; fluid ; liquid ; Liquid substance ; Exposure to ; Intravenous ; mechanical ; Mechanics ; Shortness of Breath ; Dependence ; Oral ; Source ; respiratory ; hypervolemia ; Fluid overload ; Cardiopulmonary ; success ; cohort ; hospital re-admission ; re-admission ; re-hospitalization ; readmission ; rehospitalization ; hospital readmission ; Self-Report ; Patient Self-Report ; Devices ; Reporting ; Position ; Positioning Attribute ; Congestive ; QOC ; Quality of Care ; Intervention Strategies ; interventional strategy ; Intervention ; Provider ; Leg ; preventing ; prevent ; Symptoms ; Adherence ; Data ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Monitor ; transmission process ; Transmission ; Preparation ; Process ; Cardiac ; cost ; feeding ; virtual ; manufacturing process ; Population ; prospective ; usability ; FDA approved ; data exchange ; data transfer ; data transmission ; population health ; mobile application ; mobile app ; mobile device application ; signal processing ; Data Science ; web app ; web application ; human-in-the-loop ; hospitalization rates ; COVID-19 ; COVID19 ; CV-19 ; CV19 ; corona virus disease 2019 ; coronavirus disease 2019 ; pressure sensor ; force sensor ; COVID-19 pandemic ; COVID crisis ; COVID epidemic ; COVID pandemic ; COVID-19 crisis ; COVID-19 epidemic ; COVID-19 global health crisis ; COVID-19 global pandemic ; COVID-19 health crisis ; COVID-19 public health crisis ; COVID19 crisis ; COVID19 epidemic ; COVID19 global health crisis ; COVID19 global pandemic ; COVID19 health crisis ; COVID19 pandemic ; COVID19 public health crisis ; SARS-CoV-2 epidemic ; SARS-CoV-2 global health crisis ; SARS-CoV-2 global pandemic ; SARS-CoV-2 pandemic ; SARS-CoV2 epidemic ; SARS-CoV2 pandemic ; SARS-coronavirus-2 epidemic ; SARS-coronavirus-2 pandemic ; Severe Acute Respiratory Syndrome CoV 2 epidemic ; Severe Acute Respiratory Syndrome CoV 2 pandemic ; Severe acute respiratory syndrome coronavirus 2 epidemic ; Severe acute respiratory syndrome coronavirus 2 pandemic ; corona virus disease 2019 epidemic ; corona virus disease 2019 pandemic ; coronavirus disease 2019 crisis ; coronavirus disease 2019 epidemic ; coronavirus disease 2019 global health crisis ; coronavirus disease 2019 global pandemic ; coronavirus disease 2019 health crisis ; coronavirus disease 2019 pandemic ; coronavirus disease 2019 public health crisis ; coronavirus disease crisis ; coronavirus disease epidemic ; coronavirus disease pandemic ; severe acute respiratory syndrome coronavirus 2 global health crisis ; severe acute respiratory syndrome coronavirus 2 global pandemic ; virtual visit ; virtual health visit ; remote monitoring ; telemonitoring ; Home ;

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
----
Phase II Amount
----