Talking Sleep

The Philips consent decree and the path forward

After nearly three years, the Department of Justice and the Food and Drug Administration have finally agreed to the terms of a consent decree with Philips. It states that Philips Respironics cannot manufacture or distribute new sleep and respiratory care devices in the U.S. market until certain criteria are met, unless the devices are classified by the FDA as “medically necessary.” The scope of the recall is far larger than just consumer PAP devices. This impacts sleep diagnostics – including Alice polysomnography systems, home sleep apnea test platforms, and in-lab titration devices. Here to help us understand the specifics of the consent decree are Drs. Peter Gay, Aneesa Das, and Robert Owens.

ADVENT-HF trial

The world of sleep medicine has had several large recent disruptions with COVID-19 and the Philips Respironics recall. These haven’t been the only ones. If we look back almost a decade, sleep medicine was disrupted by the SERVE-HF results and field safety notice for ResMed ASV devices. Another trial was conducted around the same time as SERVE-HF but utilized Philips ASV devices. Those results have now been published and provide some insight into the use of peak-flow-triggered ASV for those with an ejection fraction of 45% or below. Dr. Douglas Bradley is here to share his results and to offer his thoughts on the use of ASV.

OSA proteomics and metabolomics

We know that there are a billion people in the world with undiagnosed obstructive sleep apnea (OSA) and that it simply isn’t practical to have every person undergo a sleep study. Are there other methods that might be more efficient identifying those at the highest risk of OSA? Dr. Laura Castillo is a chemist who has studied biological matrices to identify biomarkers for obstructive sleep apnea. Her research involves analyzing sweat and she has found that there are specific markers for those with severe OSA and those without any OSA. Dr. David Gozal has been working in this field for many years and has published extensively. He has also studied urine proteomics as a method to identify sleep disordered breathing in children.

Acoustic stimulation for improving sleep

There are a handful of direct-to-consumer devices that claim to improve the quality of our sleep by using acoustic stimulation. What is the science behind these devices? Dr. Roneil Malkani is an associate professor of neurology in the Feinberg School of Medicine at Northwestern University. He collaborates with others to study acoustic stimulation during sleep and its impact on sleep architecture. He describes how these devices work and how clinicians should approach them.