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

Area of Science:

• Sleep Medicine
• Medical Devices
• Respiratory Disorders

Background:

• Obstructive sleep apnoea (OSA) affects millions globally, with a significant portion experiencing positional effects.
• Approximately 25% of OSA patients have events exclusively in the supine position, highlighting the need for positional therapies.

Purpose of the Study:

• To validate a novel positional vibrating device for treating positional OSA.
• To assess the device's efficacy in reducing the Apnoea-Hypopnoea Index (AHI) and supine sleep time.

Main Methods:

• A multicentre, prospective, randomised controlled trial involving 128 patients.
• Patients were assigned to general recommendations, an inactive device, or an active device group.
• Overnight polysomnography was conducted at baseline and 12 weeks, with questionnaires assessing sleep and quality of life.

Main Results:

• The active device group showed a significant reduction in AHI (30.6 to 20.4 events/hour, p<0.001).
• The active device led to a greater reduction in AHI compared to general recommendations and the inactive device (p=0.014).
• Significant reductions in supine sleep time were observed across all groups, with the active device group showing a 21.0% decrease. Total sleep time increased significantly only in the active device group, with improvements in deep sleep (N3) and REM sleep stages without fragmentation.

Conclusions:

• The positional vibrating device is effective in managing positional OSA by reducing AHI and supine sleep time.
• The device improves sleep architecture, increasing deep and REM sleep stages.
• This device presents a viable therapeutic option for patients with positional obstructive sleep apnoea.