Abstract
PURPOSE: The aim of the present study was to assess the efficacy of the Ronch®AP palatal device in treating patients with moderate and severe forms of obstructive sleep apnea syndrome. METHODS: In a randomized controlled trial 22 patients were examined with the Ronch®AP palatal device after 4 weeks of usage. Their results were compared to a control group of 30 patients who did not receive any treatment during this time. All patients included did not tolerate CPAP therapy. Among other parameters the apnea-hypopnea index (AHI) was measured using nocturnal cardiorespiratory polysomnography. Daytime sleepiness was assessed using Epworth Sleepiness Scale. Pittsburgh Sleep Quality Index was used to analyze sleep quality. RESULTS: Using the Ronch®AP palatal device AHI was reduced from an average of 35.34 ± 14.9/h to 19.18 ± 14.93/h, whereas the control group only showed a minimal mean reduction from 31.32 ± 12.76/h to 29.37 ± 17.11/h. The difference in reduction between the two randomized groups was highly significant (d = - 14.2, 95% CI 5.9-22.6, t = 3.4, df = 49.9, p = 0.001). Epworth Sleepiness Scale score was lowered from 9.18 ± 4.73 to 7.82 ± 4.14 on average and sleep quality improved by - 1.91 ± 2.31. Both changes were also statistically relevant (p < 0.005). CONCLUSIONS: The Ronch®AP device is an effective alternative treatment option for patients suffering from moderate and severe forms of obstructive sleep apnea syndrome and not tolerating CPAP therapy. TRIAL REGISTRATION NUMBER: 407-16 with approval from the local ethical committee (Ethikkommission der Medizinischen Fakultät der LMU München).