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

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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HL157291-01
Application #
10189423
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Iturriaga, Erin
Project Start
2021-03-15
Project End
2022-03-14
Budget Start
2021-03-15
Budget End
2022-03-14
Support Year
1
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Nightingale Labs Corporation
Department
Type
DUNS #
114739181
City
San Diego
State
CA
Country
United States
Zip Code
92130