Results
sleepiness, OSAS, daytime sleepiness
After the adjustment period was completed, 22 out of 30 patients tolerated Ronch®AP and were approved for polysomnographic testing. In accordance with the study’s protocol 30 patients of the control group did not receive any treatment. 14 women (23.3%) and 46 men (76.75) were included in the study. 32 patients suffered from moderate (AHI < 30/h) and 28 from severe OSAS (AHI ≥ 30/h). Patients suffering from mild OSAS could not be included. Mean age was 58.7 ± 10.9 years and mean body mass index (BMI) 26.8 ± 3.1 kg/mComparability of baseline parameters after randomizationThe effectiveness of the Ronch®AP palatal device was analyzed through the difference in parameter value between the two different times of measurement Effect of Ronch®AP therapy in comparison with no treatment: Baseline values and follow-up results after 1 month (absolute value)AHICorrespondingly, the analysis of treatment success in relation to AHI showed that the different criteria for successful treatment were more often met within the therapy group. 40.9% (Treatment success in regard to AHIEvaluating possible predictors for treatment success, the results showed that the Ronch®AP appliance proved to be more efficient in treating patients with a BMI < 30 kg/mWhile acknowledging that Ronch®AP therapy successfully reduced AHI, other sleep parameters showed no statistically significant improvement in comparison with the control group (Tables Effect of Ronch®AP therapy in comparison with no treatment: parameter differences Differences Apnea obstructivApnea centralApnea obstructivApnea centralResponse rate of treatment success in regard to different success criteria17/0100%/0%13/0100%/0%24/0)100%/0%6/0100%/0%15/1550%/50%28/293.3%/6.7%8/280%/20%10/283.3%/16.7%14/477.8%/22.2%4/0100%/0%9/1340.9%/59.1%20/290.9%/9.1%16/194.1%/5.9%12/192.3%/7.7%23/195.8%/4.2%5/183.3%/16.7%14/1646.7%/53.3%27/390%/10%6/460%/40%9/375%/25%12/666.7%/33.3%3/175%/25%6/1627.3%/72.7%20/290.9%/9.116/194.1%/5.9%8/561.5%/38.5%18/675%/25%6/0100%/0%17/770.8%/29.2%26/292.9%/7.1%6/460%/40%7/558.3%/41.7%10/855.6%/44.4%3/175%/25%6/1331.6%/68.4%16/672.7%/27.3%Subjective treatment effectiveness was evaluated by ESS and PSQI. ESS score showed a reduction in daytime sleepiness from initial 9.18 ± 4.73 to 7.82 ± 4.14 under Ronch®AP therapy, whereas the control group showed increased levels of sleepiness (ESSESS and PSQI22 patients of the therapy group answered the Ronch®AP questionnaire (Tables Therapy adherence and influential variables of Ronch®AP therapySide effects of Ronch®AP therapyCorrelation between side effects and willingness to continue treatment and