Objective: To prospectively evaluate the efficacy of the mandibular advancement device (MAD) Somnoguard in the treatment of OSA patients.
Study design and setting: Forty-four patients with OSA and noncompliant to continuous positive airway pressure were enrolled in this case series. Somnoguard is made of thermoplastic material. Direct intraoral fitting was done by an otorhinolaryngologist. Polysomnographic data concerning sleep and respiration were assessed at baseline and after familiarization with the MAD.
Results: Sleep efficiency and sleep stages distribution did not change significantly. The RDI could be reduced from 31.5+/-17.6 to 18.2+/-17.0 (P<0.05), the minimal oxygen saturation increased from 78+/-12.9 to 82+/-12.5% (P<0.05). According to standard criteria, 18 patients were cured, 12 were improved, 8 remained unchanged, and 6 worsened. Snoring time decreased from 223+/-132 to 183+/-134 minutes (P<0.05).
Conclusion and significance: With Somnoguard 68% of the enrolled OSA patients could be cured or substantially improved. It is a simple MAD for the otolaryngologist.