Talking Sleep AASM

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.

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.

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.

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.

While CPAP devices are similar across manufacturers, there are more significant differences in the advanced modalities of ventilatory support. Dr. Lisa Wolfe is well known for her granular knowledge of mechanical ventilation, including noninvasive ventilation (NIV). She discusses some aspects of NIV that may become pertinent as both sleep labs and patients transition off devices recalled by Philips Respironics. She also addresses concerns related to patients who have complex conditions such as chronic obstructive pulmonary disease (COPD), obesity hypoventilation syndrome, and neuromuscular disease.

We know that CBT-I is the gold standard treatment for insomnia, but it remains inaccessible for many due to cost or the limited availability of trained professionals. For patients with comorbid mental health disorders, insomnia treatment may improve their sleep and mental health, but sleep restriction therapy may not be the most appropriate modality. Dr. Chris Bojrab is a psychiatrist who has embraced sleep care as a vehicle to improve the mental health of his patients, and he has expertise in neurotransmitters. He discusses pharmacologic treatment of insomnia and some important considerations in those with mental health disorders.