Vibrotactile Positional Therapy for positional Obstructive Sleep Apnoea: A Multicentre Randomised Controlled Trial

<bold>Background:</bold> Newer positional therapy (PT) devices provide vibrotactile feedback to patients with positional obstructive sleep apnoea (POSA). There is scarce data on their effect on longer-term effects on sleep apnoea severity and symptoms. <bold>Methods:</bold> A randomised, parallel, double-blinded trial compared PT with sham over 3 months. Adults with POSA were randomised to either neck-worn vibrotactile PT (Night Shift™; Advanced Brain Monitoring, USA) or identical sham device. The primary endpoint was the apnoea hypopnoea index (AHI) at 3 months. Secondary analyses included the Epworth Sleepiness Scale score (ESS) and the Pittsburgh Sleep Quality Index (PSQI). <bold>Results:</bold> 120 patients were randomised. Patients had a mean±SD age of 52.7±12.3 years, mean BMI of 28.4±4.2 kg/m2, median AHI of 12.8 /hr (IQR 9.2, 18.5), mean ESS of 8.8±4.7, 94 (78%) were male, and 92 (77%) completed the trial. There was a significant improvement in the AHI of 4.4 /hr (95% CI 1.1, 7.8; p= 0.01, <bold><italic>Figure</italic></bold>) with PT compared with sham. There was a significant improvement in the PSQI of 1.0 (95%CI 0.0, 2.1; p=0.04), but not the ESS (0.6, 95%CI -0.6, 1.8; p=0.3) with PT compared to sham. <bold><italic>Figure: AHI at baseline and after 3-months of PT and Sham PT</italic></bold> <fig><object-id>erj;64/suppl_68/PA863/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig> <bold>Conclusion</bold>: PT reduced the severity of OSA and improved sleep quality but not sleepiness. Patients were minimally symptomatic and further research is needed in those with excessive sleepiness.