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SDB Devices: Do No Harm

In April 2018, the AAO-HNS participated in the FDA-sponsored workshop, “Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing (SDB) in Adults.” Other organizations that participated in the workshop were the American Academy of Neurology, the American College of Chest Physicians, the American Sleep Apnea Association, the American Academy of Sleep Medicine, and the American Academy of Dental Sleep Medicine.

AAO-HNS participants from that event presented the workshop’s findings in Monday’s session “FDA Perspective on OSA: A Growth Area for Otolaryngology.”

“Sleep is one of our growth areas,” said James C. Denneny III, MD, AAO-HNS/F EVP/CEO, who moderated the session. He pointed to the value of the inclusiveness and collaboration of the invited groups for getting on the same page regarding sleep-related issues and technologies for the patients’ benefit.

Eric A. Mann, MD, PhD, an otolaryngologist working at the FDA’s Center for Devices and Radiological Health, agreed that sleep has been a huge area of growth at the agency level, and the FDA has appointed a dedicated team to handle SDB devices. He highlighted the premarket review issues for SDB devices, including the varying definitions for key terms, the different technologies used to diagnose SDB, and the challenges that have come with the advent of digital health technology for the screening and diagnosing of SDB.

“We have to have common definitions,” said M. Boyd Gillespie, MD, of the University of Tennessee Health Science Center. “If we don’t, we might not be treating the same problem.” He reviewed common words that were discussed during the workshop—such as hypopnea, SDB, OSA, OSA syndrome, central sleep apnea, and primary snoring—and relayed the consensus of the workshop panel on the definition of each. Some words, such as apnea, were easy for the group to agree upon. But the panel could not find consensus on other words, including SDB, and decided that such terms should not be used in clinical trials as they could lead to confusion.

Kathleen Yaremchuck, MD, MSA, of the Henry Ford Health System, addressed technologies used to diagnose SDB. She highlighted the advantages and disadvantages of both a diagnostic sleep study and a home sleep apnea test. She offered clinical trial design considerations for SDB devices, including study design, how to define the control group and no treatment group, and the duration of the trial.

There is an exploding list of devices that track sleep these days, from apps to wearable fitness devices, said Dr. Denneny. The concerns about these technologies include safety, effectiveness, the concept of “do no harm,” and data analysis.

“Digital health devices are a precursor to get you in for a medical exam,” Dr. Denneny said. Workshop participants agreed these devices should complement, not replace, medical management of SDB.

Access webcasts and a full transcript of the FDA workshop.