Evaluation of Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea: A Pilot Study.

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.