A post hoc analysis of the compliance of a new forehead device about postural sleep apnea patients

Abstract

Background: In 56-75% of patients with OSA, the frequency of apneas-hypopneas are influenced by body position. A positional therapy based on vibration and placed at the forehead has proven to be effective in reducing the apnea-hypopnea index (AHI).

Objectives: To analyze the differences in use, time in supine and patient satisfaction between active device (AD) and inactive device (ID).

Methods: This is a post-hoc analysis of a multicenter, randomized, prospective, parallel controlled trial. The study sample included 87 patients > 18 years, diagnosed as positional OSA and divided in two groups (AD and ID). Questionnaires were administered to evaluate patient satisfaction Results The median (IQR) daily use of the device at week 12 was similar in both groups; (6.8 h (2.6) for ID group and 6.7 h (1.8) for AD group; p > 0.05), being always above 6.4 h throughout the follow-up period. The median percentage of time in supine position, was significantly lower in the AD group (between 2.3% and 3.1% along the follow-up period) than in the ID group (between 8,7% and 13,4%) (p <0.012 in all weeks). This difference was observed even in the first week (2.6% (4.2) for AD group and 10.6% (14.8) for the ID group; p< 0.001). The better satisfaction score obtained in the AD group was for Ease of transport (9.3±1.1) and in the ID group for Ease of use (9.1±0.8). All satisfaction items received scores higher than 8.5 in both groups.

Conclusions: The daily use of the device was high in both groups and a significant reduction in the supine position was observed in AD group compared to ID group. Patient satisfaction was high in evaluated items .The device is well tolerated and could be considered as treatment.