Drs. Neil Freedman and Barbara Phillips represented CHEST at an FDA workshop on April 16 on “Study Design Considerations for Devices Including Digital Health Technologies for Sleep-Disordered Breathing (SDB) in Adults. The other organizational participants were The American Academy of Dental Sleep Medicine; The American Academy of Neurology; the American Academy of Otolaryngology, Head and Neck Surgery; The American Academy of Sleep Medicine; and The American Sleep Apnea Association. Here are the questions that the FDA asked the panelists:
1. FDA is seeking to promote innovation and expedite the clinical development of devices intended for the diagnosis and treatment of sleep-disordered breathing (SDB). How should the following conditions (including their severity, eg, mild, moderate, severe, if appropriate) be defined for the purpose of creating appropriate inclusion/exclusion criteria for a clinical study for SDB devices?
c. Sleep-Disordered Breathing (SDB)
d. Obstructive Sleep Apnea Syndrome (OSAS)
e. Central Sleep Apnea Syndrome (CSAS)