Trial design and subjects of the study
This retrospective bi-center study was performed at the Otolaryngology, Head and Neck and Oral Surgery Department of <Blinded for review> and at the ENT Department of ‘<Blinded for review>.
Subjects eligible for the study inclusion were retrospectively selected from patients with OSA diagnosis treated in these centers. In order to evaluate and compare the effect on quality of life of two different type of treatments for OSA (CPAP and multilevel surgery), two groups of study were defined:
Group 1, OSA patients treated with TORS in a multilevel surgery setting.
Group 2, OSA patients treated with CPAP device.
The study design flow chart with inclusion and exclusion criteria of the study has been reported in Figure 1 .
In Group 1 were enrolled patients, with age between 18 and 65, treated with multilevel surgery to the <Blinded for review>, from January 2017 to February 2019. Multilevel surgery consisted in a resection of the tongue base using the Transoral Robotic Surgery (TORS) + epiglottoplasty + tonsillectomy + Barbed Repositioning Pharyngoplasty (BRP) + settoplasty and/or turbinoloplasty. This combined multilevel surgical approach is a standardized protocol, well described in the literature, that has been performed at our center for more than 10 years. Surgical steps were performed in all patients as reported in the original study of Vicini et al.(8,10,15).
In Group 2, on the other hand, have been enrolled patients treated with CPAP at the Sleep Medicine Center of the <Blinded for review>. For the study inclusion only patients with an auto-CPAP device and with a mean age between 18 and 65 years were considered.
An identical number of patients were enrolled in wo groups in order to better compare results of the two groups.