About our project
The problem we solve: - Lack of continuous representative data collection in trials and therapy. Current cough frequency monitors used usually in 24 hour window administered with low frequency in the course of trial or therapy.
- Snapshot approach. In-hospital or in-clinic assessments are too few and out of context of patient’s day-to-day activity, while suffering from random sampling issues that may mask change over time.
- Subjectivity of PROs. Individual’s self perceptions influenced by confounding factors.
- Lack of longitudinal passive measurements. Patients lack continuous indicators of their status, which can lead to inappropriate decision
making regarding healthcare seeking behaviors.
About our solution:
HealthMode Cough is a smartphone application that records sounds from the smartphone’s built-in microphone and transfers the sound files in encrypted form to the cloud storage where the data is processed to quantify cough sounds and cough frequency progresses over time. HealthMode Cough has been tested for capabilities of long-period audio data recording and data processing to automatically detect cough sounds from the collected audio data.
In the light of the recent COVID-19 pandemics, HealthMode Cough technology has been deployed to collect cough sounds to a) assess cough characteristics associated with the novel disease, b) allow individual- and population- level monitoring of cough symptom during disease outbreak. Users are able to record and contribute their cough sounds via various means, such as the HealthMode Cough application, a phone number or a website with audio recording functionality. Each of these modes of entry have been approved by central IRB.
Progress to
date:HealthMode Cough is a fully developed smartphone application, connecting to a secure cloud back-end for data storage and processing. It’s reliability and feasibility has been tested in a chronic cough patient population. The core of HelathMode Cough technology is a machine learning model trained to classify the collected audio data and yield the result in the form of cough sound counts. The model was initially developed with publicly available data, and later used in a clinical setting to assess patient-collected data. HealthMode Cough system gained traction with various academic, industry and medical expert partners, aiming to be deployed in clinical research of cough and respiratory symptoms.
About Our Team
Creator: Dan Karlin
Location: New York
Bio: Dr Karlin is the CEO at HealthMode.co. He was previously the Head of Clinical, Informatics, and Regulatory Strategy for Digital Medicine at Pfizer, having passed through a number of roles on the way to this position including Senior Director, Quantitative Medicine, Group Lead for Human Biology and Medical Informatics with Pfizer’s Neuroscience Research Unit in Cambridge, MA. He is an Assistant Professor at Tufts Medical Center in Boston, and had been the Director of Psychiatry Informatics, and the Associate Training Director for Psychiatry. His primary research interests are neuropsychiatric drug development, medical informatics, cognition in clinical medicine, and methods for medical education, especially as these relate to decision-making strategies used by medical professionals. In addition, Dr Karlin is actively involved in designing and implementing information systems and resources for clinical and research use. Dr Karlin trained in Psychiatry at Tufts Medical Center, attended medical school at the University of Colorado School of Medicine, and graduate school for Clinical Informatics and Cognitive Science as well as undergraduate studies in Neuroscience and Behavior at Columbia University. He is board certified in Psychiatry, Addiction Medicine, and Clinical Informatics.
Title: CEO
Advanced Degree(s): MD MA
How We Help Patients
In the longer term, data gathered during this study may prove HealthMode Cough to be a low-cost, easy to use and powerful tool to help health authorities screen large populations for COVID-19, and improve patient outcomes by making telehealth visits more impactful during a time of mandatory quarantine and social distancing.
How We Help Physicians
HealthMode Cough is a mobile software application that enables automated, remote, continuous cough monitoring of individuals, healthcare environments and public spaces. Physicians will receive objective highly-granular patient data collected over a period of time. This may help to support decision making around targeted treatment for the patient.
How We Help Hospitals
HealthMode Cough enables monitoring of cough in the clinic, at home, and in the wild.
How We Help Partners
HealthMode Cough is a digital measurement tool deployable in clinical trials, post-approval settings, and available as a drug-device combination.
Innovation Details
Intellectual Property Summary
HealthMode Cough technology will soon be registered as a trademark.
Clinical Information
https://www.clinicaltrials.gov/ct2/show/NCT04326309
Reviewed by IRB Advarra
Approval no: Pro00042756
Regulatory Status
We're in the stage of preparation for the initial Q-Sub meeting. As a first step, we are aiming for FDA clearance as Class I Software as a medical device.
How we will use the funds raised
Accelerate the development, enhance the technology, and also achieve robust clinical validation in a shorter time. We have a broadly deployable product to monitor and classify cough in COVID-19 and other respiratory tract infections in large patient populations.
Thank You
HealthMode Cough is a technology we've been working on for over 18 months and the financial contribution would help us to speed up the development process and enable us to quickly react to the global pandemic outbreak. The ultimate goal is to go beyond the cough counter and classifier and also develop a decision support tool for clinicians. We have a clear pathway towards robust clinical validation, FDA clearance and CE mark in 2020/2021.
