Abstract: Background: Obesity hypoventilation syndrome (OHS) is commonly treated with manual adjusted noninvasive ventilation (NIV). Auto-adjusted NIV devices are now available but there is not high evidence in effectiveness because there are absence of long-term clinical trials comparing these treatment modalities. Methods: In this multicenter, blinded, parallel groups, non-inferiority and cost-effectiveness clinical trial carried out in 12 centers in Spain, we randomly assigned 194 naïve OHS patients to receive treatment with auto-adjusted NIV or manual adjusted NIV. The objective was to assess long-term effectiveness for at least 1 year between arms using PaCO2 as the primary outcome and other respiratory outcomes, polysomnography (with identification and correction of patient-ventilator asynchronies in the manual adjusted NIV group), office blood pressure (BP) measure, 24 hours BP monitoring, health related quality of life (HRQL) tests, health resource utilization (primary care, specialist and emergency visits; hospital and intensive care unit admissions), cardiovascular events, dead incidences, need of ambulatory oxygen therapy, website real-time ventilator parameters (tidal volume, inspiratory and expiratory pressure, flow and leak) and cost-effectiveness relationship between arms as secondary measures. The non-inferiority premise was -2 at the lower confidential interval (CI) to 95% for the change in PaCO2 between arms. Intention-to-treat analysis was performed. Finding: 105 patients in the auto-adjusted NIV group and 89 in the manual adjusted NIV group were randomized. The median (IQR) follow-up was 13.02 (12.21;16.19) months. The mean [95% CI] improvement in PaCO2 was -9.15 [-9.63-8.67] mmHg in the auto-adjusted NIV group and -8.89 [-9.32;-8.46] mmHg in the manual adjusted NIV group, mean difference 0.26 ([-1.9 to 2.41]; p = 0.815) between groups. The change in other arterial blood gases, spirometry, 6 min. walk distance test, polysomnography, BP and HRQL outcomes were similar between arms. Health resource utilization, cardiovascular events and dead incidences, need of ambulatory oxygen therapy, ventilator parameters, patient-ventilator asynchronies and adverse events were also similar between arms. Cost-effectiveness relationship was favourable to auto-adjusted NIV group with a saving of 516.45€ per patient-year. Interpretation: In stable patients with OHS, auto-adjusted NIV and manual adjusted NIV have similar long-term effectiveness. Given that auto-adjusted NIV has lower complexity and cost, auto-adjusted NIV may be preferred for the clinical practice.

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