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

RATIONALE: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION DETAILS: The trial was registered at www.clinicaltrials.gov (NCT03336515).

Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial.

BACKGROUND: The influence of body position in obstructive sleep apnoea patients is well known. A positional therapy device placed at the forehead has proven to be effective in reducing the severity of positional obstructive sleep apnoea (POSA) symptoms. The aim of the study was to evaluate patients' therapy compliance and satisfaction in the short term and mid-term. METHODS: A post hoc analysis of a randomised controlled trial was conducted using an inactive device (ID) or an active device (AD) for 3 months. The primary outcomes were device usage and the percentage of patients with good compliance (defined as device use for more than 4 hours per night and more than 70% of nights per week). Secondary outcomes included time spent with head in the supine position, patient satisfaction and side effects. RESULTS: The median duration of using the device was 6.9 hours in the ID group and 6.7 hours in the AD group (p=0.309), and the durations were similar throughout the follow-up period and from the first day of use. The percentage of patients with good compliance was similar and greater than 60% in both groups. The median time spent with head in the supine position was significantly lower in the AD group (2.9%) than in the ID group (12.4%) since the first day of treatment. Both groups showed satisfaction scores values above 8.5 (out of 10) in all items, while side effects were scarcely reported. CONCLUSION: High device compliance was achieved in POSA patients, both in terms of device usage time and percentage of days used. Patients were highly satisfied, and the device effectively reduced the time spent with the head in the supine position from the first day of use.