Update: FDA workshop on medical devices for SDB


 

2. Polysomnography (PSG) has been widely accepted as the “gold standard” test for the diagnosis of OSA and primary snoring. However, home sleep apnea testing (HSAT) has emerged in recent years as an alternative or complementary diagnostic tool for SDB.

a. Can HSAT be used for establishing a baseline diagnosis and for the collection of clinical performance data for device trials for OSA, CSA, or primary snoring? If so, what are the recommended parameters that should be collected by an HSAT (eg, nasal pressure, oximetry, chest and abdominal respiratory inductance plethysmography)?

b. What constitutes a technically adequate test (either PSG or HSAT, if appropriate) for establishing a baseline diagnosis of SDB for device studies (eg, number of hours, number of nights)?

Pages

Next Article: