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

ABSTRACT

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.