CoughMonitor Suite is Hyfe’s research product and consists of:

• the CoughMonitor, a smartwatch that counts coughs
• the CoughMonitor Companion App, a phone-based app available on iOS and Android
• The CoughMonitor Suite Dashboard, a web-based app for managing participants

The CoughMonitor smartwatch is a watch running cough monitoring software, intended to be used by researchers in IRB-approved clinical trials. The CoughMonitor quantifies coughing by passively detecting and timestamping cough. Cough data (timestamps) is transmitted to Hyfe’s Cloud via Bluetooth using a phone based app named CoughMonitor Companion App.

Researchers can access cough data via a web-based dashboard in real time. This tool is designed for research trials that include objective cough frequency as an endpoint.

Hyfe provides a timestamp of each cough. This longitudinal continuous cough frequency data is accessible in near real time. In addition, Hyfe tracks whether the watch is being charged or not, and whether it is being worn or not (using the PPG sensor).

A clinical validation study demonstrated that the hourly coughs generated by the Hyfe system - when used in real-world conditions - correlated very closely with the hourly coughs counted by trained human annotators (Lin's Concordance Correlation Coefficient of 0.975). The same study showed a median sensitivity to cough-seconds of 90%, with fewer than 1.6 false positives per hour.

The use of the data depends on your research objective, though it is important that data collected by the CoughMonitor is only used observationally, never to drive clinical decision-making.

Hyfe´s cough-monitoring technologies have been employed in over 50 trials, and here are some of the different use cases for cough monitoring:

• Cough Science: To describe the natural history of cough in specific disease in order to gain fundamental disease insights and design better intervention trials
• Drug Development: To monitor changes in cough in drug development trials spanning proof of concept to regulatory enabling Phase III studies.
• Disease Management: For research designed to develop or test predictive algorithms that detect early stages of (or deterioration in) specific diseases.

Yes! Hyfe has a dedicated team that provides analysis services as needed. For example,  our statisticians can use standard statistical approaches to determine feasibility (measured as adherence) acceptability (with a qualitative exit interview), cough rates, patterns, concordance of subjective and objective measures including clinical data and bouts (using various definitions). In addition, implications for future study design can be modeled on the impact of cough frequency and variability of sample size requirements for intervention studies.

Yes. Hyfe signs agreements with all research partners. You can download Hyfe’s standard Data License Agreement and the Device Loan Agreement. Alternatively, you can propose using your institution’s templates.

No, CoughMonitor Suite is not a medical device. It is a research tool used to measure cough  frequency in studies. It is not intended for use in diagnosing, treating, or monitoring patients. It is not intended for clinical decision making and does not provide medical evaluations. The system is solely intended to assist in the collection of objective data to support scientific research.

Hyfe takes user privacy extremely seriously. Hyfe monitors sound levels through the watch´s microphone. The first “peak detection” algorithm identifies explosive sounds that are similar to a cough sound. A second “cough recognition” algorithm classifies these sounds as either coughs or non-coughs. This classification process happens on the watch itself thus no acoustic data ever leaves the devices. Only timestamps of the recognized cough sounds are transmitted to the cloud.

Read the CoughMonitor Suite privacy policy here: https://www.hyfe.com/cms-privacy-policy

For academic or medical research, ethical approval is required, since any research on human subjects typically requires IRB approval.

Our internal data processes are HIPPA and GDPR-compliant, and in concordance with ISO 27001.

The CoughMonitor watch is a consumer device, with the relevant consumer certificates including a CE mark.

CoughMonitor is optimized for the best performance at a distance of up to 3ft (~90cm). CoughMonitor can detect other people’s coughs if it is in very close proximity to other coughing people. Based on our investigations, other people’s coughs captured in real world environments (e.g., as participants visit offices, take the metro, go grocery shopping, etc) is usually very minor and therefore not having an impact on one's longitudinal cough trend and pattern.

While this is generally not a concern for research trials, some studies have an exclusion criteria that excludes individuals who are living with other chronic coughers.

Cough data (timestamps only) are transmitted via an encrypted connection to Hyfe’s secure cloud. Data can be retrieved via a web-based dashboard. The cough data is never linked to personal identifiers and can be deleted upon request.

Yes, you can collect PROs (such as the NRS) using the CoughMonitor Companion App.

The phone app is compatible with the vast majority of phones in use. Specifically, Android phones running version 12.0 and above, as well as iOS devices on version 16.0 and newer. Minimum requirements for the Bluetooth Version: v4.2.