Evaluation of a prefabricated adjustable thermoplastic MAD (MyTAP™) for treatment of OSAS

Aim: To assess the effectiveness of a prefabricated adjustable thermoplastic mandibular advancement device (PAT-MAD; MyTAP™) in the treatment of OSAS. Methods: Sixteen adult patients (13 men and 3 women) with a mean age of 53.88 ± 12.88, with diagnosed mild, moderate or severe OSAS on polysomnography (PSG) were recruited. Respiratory parameters included apnea-hypopnea index (AHI), oxygen desaturation index (ODI) and the lowest O2 saturation (Low SpO2) were measured before (T0) and after 6 months (T1) of treatment. Results: AHI index decreased from 29.9 ± 19.97 to 9.59± 8.94 after treatment (p – value =0,0023), ODI index also decreased from 21.06 ± 16.05 to 8.20± 9.67 after treatment (p – value =0,0129). No statistically relevant decrease of Low SpO2 was observed (p – value =0,8374) after treatment. Significance for all statistical tests was set at p – value < 0.05. An additional study compared the AHI > 30 sub – population with the AHI < 30 sub – population. The AHI > 30 sub – population consisted of 5 patients, all males, mean age 47.6 ± 14.04 and initial AHI 56.02 ± 3.60. The AHI < 30 consisted of 11 patients, 8 males and 3 females, mean age 56.73 ± 11.88 and initial AHI 18.03 ± 5.28. ANOVA test and Tukey test proved a statistically relevant decrease in the AHI index from T0 to T1 in the sub – population AHI >30 with p – value < 0.05. Other comparison showed no statistically significant difference. Conclusion: MyTAP™ is a device for trial use, but it appears also to be an effective and economical option for OSAS treatment, improving the polysomnographic parameters.