Georg Nilius, Mehran Farid-Moayer, Chia-Mo Lin, Lennart Knaack, Ying-Piao Wang, Dominic Dellweg, Ricardo Stoohs, Joachim Ficker, Winfried Randerath, Markus B Specht, Wolfgang Galetke, Hartmut Schneider
BACKGROUND: Intraoral devices, with or without negative oral pressure, can stabilize the oropharynx and reduce obstructive sleep apneas. We tested the hypothesis that treatment with the iNAP® Sleep Therapy System, which applies negative oral pressure through an intra-oral appliance, would reduce the severity of obstructive sleep apnea in a multi-center, prospective, first-night-randomized-order cross-over study. METHODS/PATIENTS: 130 patients fulfilled the entry criteria (age <75, AHI 15-55, BMI <33), and 63 entered the primary endpoint cohort (Total Sleep Time ≥4 h/night on the baseline polysomnogram and an oral negative vacuum time maintained by iNAP® ≥ 4 h/night and total sleep time ≥4 h/night during the first treatment study)...
April 17, 2024: Sleep Medicine