Kram JA, et al. – A pilot study was undertaken 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. Results of this study suggested that cNEP seemed to be safe and effective during short–term use in subjects with OSA.

Methods

• It was a prospective, open-label pilot study.
• For this investigation, subjects with documented OSA selected from the patient population at one sleep clinic.
• Application and titration of cNEP during overnight polysomnography was the main the intervention.

Results

• Based on the results of the present study, of the fifteen subjects studied (mean apnea-hypopnea index [AHI] at baseline, 43.9 events/h), thirteen (87%) were responders to cNEP: nine had an excellent response (AHI < 5 events/h) and four had a partial response (AHI < 50% baseline and < 15 events/h).
• The results indicated that 3 minor, self-limited adverse events occurred, which seemed related to contact pressure of the cNEP device on the skin.