New forehead device in positional obstructive sleep apnoea: a randomised clinical trial.

Abstract

Approximately 60% of the patients with obstructive sleep apnoea suffer from a positional effect, and approximately 25% of these patients present events only in the supine position. To validate a new positional vibrating device and evaluate its efficacy in reducing the Apnoea-Hypopnoea Index and the total sleep time in the supine position without disturbing sleep. A total of 128 patients were recruited for this multicentre, prospective, parallel, randomised controlled trial and were distributed in three arms (general recommendations, inactive and active device). Full overnight polysomnography was performed at baseline and at 12 weeks. Anthropometric variables and sleep and quality of life questionnaires were collected at 4, 8 and 12 weeks. The Apnoea-Hypopnoea Index decreased from 30.6 per hour to 20.4 per hour (p<0.001) in the active device (AD) group. In this group the reduction was 2.3-fold and 3.3-fold than the ones in the general recommendations (GR) and inactive device (ID) groups, respectively (p=0.014). Sleep time in supine position decreased 17.7%±26.3% in GR group (p<0.001), 13.0%±22.4% with ID group (p<0.001) and 21.0%±25.6% in the AD group (p<0.001). Furthermore, total sleep time increased significantly only in the AD group (22.1±57.5 min, p=0.016), with an increased percentage of time in the N3 (deep sleep) and N3+REM (rapid eye movement) stages, without sleep fragmentation. The device was effective in reducing the Apnoea-Hypopnoea Index and time spent in the supine position also in improving sleep architecture. Therefore, the device could be a good option for the management of patients with positional obstructive sleep apnoea. The trial was registered at www.clinicaltrials.gov (NCT03336515).