Randomised controlled trial of remote monitoring of non-invasive ventilation in patients with obesity hypoventilation syndrome and coexisting obstructive sleep apnoea

Background Chronic hypercapnic respiratory failure in patients with Obesity Hypoventilation Syndrome (OHS) and coexisting Obstructive Sleep Apnoea (OSA) is commonly treated with non-invasive ventilation (NIV). However, adherence to NIV can be limited. The primary aims of this study were-to assess whether remote monitoring of NIV could improve NIV adherence in patients established on NIV with low adherence. Methods This was a prospective, randomised, and controlled trial with a two-arm parallel group design, testing remote monitoring of home NIV for 3 months in patients with OHS and coexisting OSA who have previously had low NIV adherence, as defined by less than 4 h of usage per night. The study was approved by the research ethics committee/Health Research Authority (HRA:270108); it was registered at ClinicalTrials.gov (05/2021; NCT04884165 ). Results A total of 32 participants were enrolled and randomised to intervention (n=16) or usual care (n=16). The study arms were similar in age (61.5(49.2;70.2) versus 66.5(51.0;71.0)years), gender (male:female, 10:6 versus 11:5) and body mass index, BMI (37.7(34.0;48.4) versus 42.8(39.7;48.2)kg·m −2 ). NIV usage at baseline was low in the intervention (1.2 (0.0; 2.1) hours/night) and the usual care arm (1.0 (0.0; 2.0) hours/night. In the intervention arm, ΔNIV usage was +0.3 h (95%CI-0.1;3.2)(p=0.48) and in the control arm, ΔNIV usage was +0.5 (95%CI-0.5;2.0)hours/night (p=0.32). The between group difference in the primary outcome (−0.2 (95%CI-2.3;2.0)hours/night) and quality of life outcomes did not differ significantly between the intervention and usual care arms. Conclusion This trial did not show any benefit of remote monitoring of NIV in patients with OHS and coexisting OSA over any usual care at 12 weeks, 68.75% of patients still used NIV insufficiently. Although some patients improved in adherence in both arms, our findings highlight the challenges of long-term NIV for patients with low long-term adherence.