INNOVATION ARTICLES THE IDEA SUBMISSION PORTAL FROM MEDTRONIC
Dr. Hyekyun Rhee
According to The Global Asthma Report 2014, an estimated 334 million people suffer from asthma with the greatest disease burden in adolescents (10-14) and the elderly (75-79). In addition, 8.6% of young adults experience asthma symptoms such as wheezing and shortness of breath. Not only a disability that can severely limit activities, when improper management can lead to premature death.
Engaging adolescents in asthma disease management can be challenging with patients having poor symptom perception and treatment adherence or unreliable technique. Yet accurate symptom monitoring is essential to treatment effectiveness. A recent study tested a novel symptom monitoring device in adolescents aged 13-17. Providing continuous and accurate symptom tracking, teenage patients were able to monitor asthma symptoms and take action with minimal disruption to daily routines. Researcher Dr Hyekyun Rhee, Associate Professor, University of Rochester School of Nursing, highlights that many adolescent asthma sufferers are not always aware of symptoms, although the sounds can be heard quite easily. “Teens are very inaccurate in recording their symptoms. They could be talking with me, wheezing to the point of almost passing out and they aren’t aware of it,” she said.
After ten years of working with asthmatic teens, Rhee began to envision a compact device that could record events 24/7. “My initial thought was that as these sounds can heard by the naked ear, perhaps a machine can be created to pick-up them up and an algorithm created for pitch, amplitude and frequency,” she said. Working with an engineer, Rhee designed an algorithm for an iPod that does not record the sound itself, but counts the event. Therefore, the data takes up very little space. The iPod was chosen as teens could carry the device easily without risk of embarrassment. At night, patients placed the device beside their bed to continue monitoring symptoms, a key benefit monitoring during sleep has been a long-standing challenge. “Often key events are missed because they occur at night,” she said.
While other listening devices have been used in the past to monitor asthma symptoms, Rhee stresses that they have been impractical. “Other applications are used in laboratory conditions without normal, external noise and require expert analysis of the data,” she said. This approach is not cost effective or reflect a patient’s daily life.
MY INITIAL THOUGHT WAS, AS THESE SOUNDS CAN BE HEARD BY THE NAKED HUMAN EAR, PERHAPS A MACHINE CAN BE CREATED TO PICK THEM UP AND AN ALGORITHM CREATED FOR PITCH, AMPLITUDE AND FREQUENCY.
A small three phase trial tested development, validation/user acceptability and post hoc validation. Over seven days, 84 patients tested the device in Phase 2. Most participants found the device easy to use and convenient. Initially false positives also proved troublesome, but with further refinement these were resolved. In this first device, patients carried an iPod with a small mic attached to their shirt collar for event recording. Limited battery power proved to be a significant issue and an additional battery pack was attached. The larger battery pack made for a bulky device and the mic lead proved annoying. Data displayed numerically was less user-friendly than graphical trend representation.
Overall teens were very receptive to the device, were more aware of their symptoms and received positive feedback from peers, opening opportunities to discuss their asthma with others. Some participants said that increased awareness driven by the device led to changes in their asthma self-management.
Since this first trial, the device has undergone significant development. A much more compact device with a wireless mic records symptoms and patients can then download data to an iPod, smartphone or computer to see trends and adjust treatment. In January 2015 the new system won a CES Innovation Award at the annual Consumer Electronics Show. Additional planned evolutions include an App.
Rhee is looking forward to another clinical trial with much larger patient numbers to provide hard data on outcomes including improved symptom management, reduced clinical visits and improved Quality of Life that possibly could show reduced healthcare costs, as well as improved symptom control. “There should be another rigorous trial to test new data. I’d like to see a long-term follow-up of two to three years,” she said.