The RonchAP® palatinal device: A conservative approach in treating obstructive sleep apnea syndrome—a randomized, controlled study

Abstract

PurposeThe 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.MethodsIn 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.ResultsUsing 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).ConclusionsThe 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 number407-16 with approval from the local ethical committee (Ethikkommission der Medizinischen Fakultät der LMU München).