Study objectives: To determine if the application of continuous negative external pressure (cNEP) is effective and safe in individuals with obstructive sleep apnea (OSA) during an overnight in-laboratory sleep study.
Methods: A prospective, open-label pilot study in subjects with documented OSA recruited from the patient population at one sleep clinic. The intervention was application and titration of cNEP during overnight polysomnography.
Results: Of the 15 subjects studied (mean apnea-hypopnea index [AHI] at baseline, 43.9 events/h), 13 (87%) were responders to cNEP: 9 had an excellent response (AHI < 5 events/h) and 4 had a partial response (AHI < 50% baseline and < 15 events/h). Three minor, self-limited adverse events occurred, which appeared related to contact pressure of the cNEP device on the skin.
Conclusions: In this pilot study, cNEP appears to be safe and effective during short-term use in subjects with OSA. Further studies are warranted.
Keywords: investigational therapies; medical device; negative pressure therapy; obstructive sleep apnea.
© 2017 American Academy of Sleep Medicine