Local Pulmonary Patients Invited To Participate In Research Trial

The Sylvee device with its app.

The Pulmonary, Critical Care and Sleep Disorders Institute of South Florida (PCSI), an integrated pulmonary and chest specialty group in Palm Beach County, is now recruiting patients to participate in a research trial. Patients who meet the study criteria to participate will be compensated for their time.

The purpose of the study is to validate Sylvee, a medical device that monitors pulmonary volumes, trapped air, respiratory and heart rates, breathing sounds, and temperature. Sylvee uses ultrasound technology to distinguish the type of sound produced in the lungs. For example, if air is trapped, the sound will differ from that produced after blowing air out of the lungs. The sensors in the device are then connected to a smartphone app, where results are made available for healthcare providers, patients or their caregivers to monitor lung function and discover a problem early.

Sylvee gathers data on how the estimated 100 million people suffering from COPD, asthma and COVID-19 might optimize their day-to-day respiratory health. The PCSI study will also specifically assess patients with long-COVID syndrome to determine if they are trapping air as COPD patients do.

Dr. Luis Javier Peña-Hernández felt it was essential to participate in this research trial and has hope for what this will do for patients and medicine going forward. He and his team find the product to be the potential next-generation method to accurately measure the degree of airway obstruction.

“In the future, there is no doubt that we will implement more and more accurate technology to early identify those patients who are developing exacerbations of their chronic conditions, to intervene early and prevent hospital admissions, hospital-related complications, deterioration of the quality of life and even death. This product could be a game-changer in our mission to achieve that goal,” Peña-Hernández said.

Sylvee, invented by Respira Labs, is worn on the lower part of the rib cage using adhesive patches. It has embedded speakers and microphones that measure changes in acoustic impedance as a proxy for changes in lung air volume. The device is currently in the prototype stage, pending FDA approval.

Inclusion criteria for long-COVID patients are men or women over age 21 with a history of confirmed COVID-19 infection. Patients must demonstrate the persistence of symptoms, such as dyspnea or increased respiratory effort, fatigue, chest pain or cough 28 days or more after COVID diagnosis. Participants must also have a negative history of smoking and a body mass index (BMI) less than 30. Inclusion criteria for healthy subjects are men or women over age 21 with no previous history of smoking nor diagnosed chronic lung conditions. Patients must be vaccinated against COVID-19 and have a BMI under 30. Participants in both test groups will be reimbursed for study participation at $100 for each completed visit, for a possible total of $300 at the end of the study. Payments will be made with Amazon electronic gift cards. For more info., contact karen@respiralabs.com.

“We are committed to providing our patients the opportunity to benefit from this and other evolving technologies that will impact their well-being and their health. This research trial opens the door to apply cutting-edge technology for inpatient home monitoring, a field in which we have been pioneers during the last few years,” Peña-Hernández said.