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Asthmagram: objective assessment of asthma symptoms in children

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL127868-01
Agency Tracking Number: R41HL127868
Amount: $207,102.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA14-072
Timeline
Solicitation Year: 2015
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-01
Award End Date (Contract End Date): 2016-08-31
Small Business Information
2605 INDIAN CREEK ROAD
Diamond Bar, CA 91765-3356
United States
DUNS: 079424567
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 RUEYKANG CHANG
 (626) 608-8555
 ssedano.neovative@yahoo.com
Business Contact
 SANDRA SEDANO
Phone: (626) 608-8555
Email: ssedano.neovative@yahoo.com
Research Institution
 NEOVATIVE, INC.
 
2605 INDIAN CREEK ROAD
DIAMOND BAR, CA 91765-3356
United States

 Domestic nonprofit research organization
Abstract

DESCRIPTION provided by applicant Asthma is the most common chronic illness of childhood but many children have poorly controlled symptoms causing morbidities hospitalizations and costs The first step toward good asthma control is accurate assessment of symptoms Recall of the frequency and severity of symptoms is the cornerstone of asthma assessment Unfortunately recall by parents or young children is prone to bias and error Symptoms are often underreported thus misguiding therapy A reliable way to measure asthma symptoms over time is urgently needed to improve asthma control in young children We propose to develop a wearable electronic device the Asthma gram to objectively assess asthma control The Asthma gram is a small patch placed at the supra sternal notch straddling the sternocleidomastoid SCM muscles It will record and monitor respiratory sounds for up to weeks Data on symptoms of coughing wheezing and retractions in relation to triggers such as exercise and cold air exposure can then be analyzed Our goal is to develop the Asthma gram for accurate assessment of asthma control in children to aid management including detection of exercise induced asthma We have specific aims In Aim we will complete the engineering development of the Asthma gram patch The Asthma gram includes accelerometers tri axial inertial accelerometer for movement and postural sensing and contact accelerometer for acoustic sensing embedded on a microelectronics platform Eco BT with a real time clock A thermistor will be mounted to detect ambient cold air Two force sensing resistors over the SCM muscles will determine if wheezing episodes are associated with suprasternal retractions In Aim we will implement the user interface UI on smart mobile devices There will be different action modes Nocturnal Exercise Hour and Before After In Aim we will develop a cross platform host PC program for the Asthma gram Report This will be a program that can import and analyze the data and generate the Asthma gram Report for clinical interpretation In Aim we will validate the Asthma gram as a clinical assessment tool Children with asthma will be recruited years old We will conduct a study of children admitted to the hospital ward for asthma exacerbations to validate the wheezing and coughing detection algorithms Once the device is fully bench tested and the algorithms validated we will recruit children for testing the Hour Mode for assessing daytime and nocturnal symptoms and children for testing the Exercise Mode for detecting exercise induced asthma Participants will wear the Asthma gram for days Achieving the aims will result in a validated Asthma gram system ready for clinical trials To accelerate commercialization following Phase I we will apply for Phase II funding for clinical trials start the process for an FDA submission and approach investors for funding

PUBLIC HEALTH RELEVANCE Although asthma is the most common chronic illness of childhood many children are poorly controlled because it is difficult to assess their symptoms Our goal is to develop the Asthma gram a small patch placed at the lower neck which will monitor asthma symptoms coughing wheezing and retractions day and night for up to weeks The Asthma gram will provide objective accurate records of asthma symptoms which can be used to guide therapy and prevent acute exacerbations and morbidities

* Information listed above is at the time of submission. *

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