Sommetrics presented promising interim updates on its pivotal SUPRA study (Study Using Negative Pressure to Reduce Apnea) at the tri-annual XVII International Symposium on Sleep and Breathing in Auckland, New Zealand.
The presenter was Kingman Strohl, MD, program director of sleep medicine at University Hospital and professor of medicine at Case School of Medicine. He is the global principal investigator for the study.
The SUPRA trial is intended to assess the treatment benefit and safety of Sommetrics’ flagship aerSleep II product in those with moderate and severe obstructive sleep apnea who are unable to use CPAP therapy. The self-contained and non-invasive aerSleep II device externally applies a mild vacuum to the neck to expand the upper airway, eliminating the need for a face mask or tether of any kind.
Strohl’s interim update highlights the initial treatment benefits for subjects who successfully acclimated to wearing the device and exhibited a response to the single vacuum pressure being tested. In these 27 subjects, the apnea-hypopnea index was reduced from 27.5 ± 10.5 (mean ± standard deviation) at baseline when the aerSleep II device was not being worn to 8.7 ± 5.7 on treatment.
Nine of 10 subjects who have completed six months of home use exhibited further reduction in AHI to 6.9 ± 5.5. To date, side effects have been mostly mild, self-limited skin irritation on the neck. Importantly, aerSleep II appears to be well tolerated, as evidenced by standard measures of treatment compliance in those who have completed six months of home use.
“There is strong optimism at the SUPRA study sites and enthusiasm among study participants about aerSleep II. To date, we are pleased with the excellent safety profile of the device and its utility as a new class for OSA therapy. We look forward to reporting on aerSleep’s effectiveness when the study is completed,” says Strohl in a press release.
SUPRA builds upon favorable clinical study results seen with a first-generation aerSleep I device, which demonstrated a reduction in apnea and a favorable safety profile in multiple earlier studies conducted in the US and Canada. These studies were the basis of a Health Canada Medical Device License for aerSleep I and the Breakthrough Device designation by the FDA for the second-generation aerSleep II product.
Enrollment in the SUPRA trial is currently ongoing. aerSleep II is an investigational device and has not been cleared or approved for sale in the US or any jurisdiction.