By Jessica Schmidt, MA, FACHE, RPSGT, CCSH
BRPT President
I was recently invited to participate in a Food and Drug Administration (FDA) Workshop entitled “Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.”
The goal of the workshop was to examine the appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of Sleep Disordered Breathing (SDB) in adults. Study design considerations discussed included definitions for SDB conditions, inclusion/exclusion criteria for studies of these conditions, use of SDB assessment technologies, controls, and study endpoints.
It was a robust day of discussion on whether or not we are at a point in which HSAT can replace the current gold-standard in-lab PSG for purposes of certifying new devices, including diagnostic technologies and new therapeutic options. The overall consensus was that the home setting is lacking in control and that reason alone poses significant challenges to standardization.
The group agreed that any HSAT used in device trials should include oximetry, flow, and some way to differentiate types of apnea. In addition, it was determined that oximetry alone is not sufficient. PAT is widely regarded as a sufficient technology for OSA detection. While sleep staging may not be necessary, if it were omitted one should consider multiple nights of recording to reduce “first night effect.” The group also agreed that using HSAT for central sleep and hypoventilation disorders is insufficient. Finally, the panel noted that the explosion in un-regulated wearable technology presents a challenge to well-validated diagnostic methods.
The workshop was recorded in its entirety and can be viewed here:
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596147.htm