Dispersed Clinical Validation of the Hyfe Cough Monitoring System

The Hyfe Cough Monitoring System is investigational, which means that it has not been approved by the Food and Drug Administration (FDA). This study is funded by Hyfe, Inc. and executed under the direction of Dr. Peter Small (the Investigator). The study will run until thirty (30) participants have completed the study

The Primary objective is to assess the agreement in cough counting between the Hyfe Cough Monitoring System and human listeners on an hour by hour basis when used by individuals with problematic cough under common living conditions using a Bland-Altman analysis.

The Hyfe Watch, along with the companion app, is part of the Hyfe Cough Monitoring System. It does not compromise the users provacy as it only retains the time of day associated with each cough. When the system detects a short explosive sound, it runs a brief "snippet" of that sound through a cough detection algorithm on the watch. If the algorithm deems the sound to be a cough, the device records the exact time that the cough occurred, and sends this time stamp to the companion app. The companion app does not access any personal information on the phone and is only used to "collect" the times at which a participant coughed from the Hyfe Watch and send them digitally to the researcher.

At the end of the 24 hours monitoring period envisiones, participants will be contacted by video call and asked to download this information from the companion app and send this to the Investigator. The use of the Hyfe Cough Monitoring System will not lead to additional medical interventions or changes to medical care.

In contrast, the sound recording watch will record all ambient sounds during a 24 hour period. This is necessary for the investigator to get an independent count of a participant´s coughing. As such, the sound recording watch will record conversations and those in the participant´s environment during this 24 hour period. It is important to let others in the environment know that sound is being recorded. The recordings will not be directly linked with the participant´s identity and will only be listened to by researchers who are trained in how to ensure the privacy of this data.