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Rationale: Noninvasive ventilation (NIV) is an effective treatment in obesity hypoventilation syndrome (OHS) with severe obstructive sleep apnoea (OSA) but there is paucity of evidence in OHS patients without severe OSA phenotype. Methods: In this multicentre (16 sites in Spain), open-label parallel group clinical trial, we randomly assigned 98 stable ambulatory patients with untreated OHS and apnoea-hypopnoea index Results:49 patients were randomised in each group and 48 patients were analysed in each one of them. During a median [IQR] follow-up of 4.98 [2.98; 6.62] years, mean (SD) hospitalization days/year was 2.60 (5.31) in the control group and 2.71 (4.52) in the NIV group [adjusted rate ratio (95% CI) 1.07 (0.44; 2.59) (p = 0.882)]. Cardiovascular events occurred in 11 (23%) participants in the control group and 10 (21%) in the NIV group (hazard ratio (95% CI) 0.96 (0.40;2.30), p=0.927). Similar results were observed in the per-protocol analysis [rate ratio (95% CI) 1.21 (0.43;3.41) (p=0.717)]. Death occurred in 9 (19%) participants in both arms (adjusted hazard ratio (95% CI) 1.07 (0.41;2.82), p=0.893). Similar results were found in the per-protocol analysis [rate ratio (95% CI) 1.38 (0.50;3.79) (p=0.529)]. Conclusion: In stable ambulatory patients with OHS without severe OSA, NIV and lifestyle modification had similar long-term hospitalization days-year. Larger studies are necessary to better determine the long-term benefit of NIV in this subgroup of OHS.

Rationale: Obesity hypoventilation syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials have assessing the impact of long-term noninvasive ventilation (NIV) or CPAP on cardiac structure and function assessed by echocardiography are lacking. Methods: In a pre-specified secondary analysis of the largest multicenter randomized controlled trial of OHS〔Pickwick project, n=221 patient with OHS and coexistent severe obstructive sleep apnea (OSA)〕, we compared the effectiveness of 3 years of NIV and CPAP on structural and functional echocardiographic changes. At baseline and annually during 3 sequential years patients underwent transthoracic two-dimensional and doppler echocardiography. Echocardiographers were blinded to the treatment allocation. Statistical analysis was performed using a linear mixed-effects model with a treatment group/repeated measures interaction to determine the differential effect between CPAP and NIV. Results:196 patients were analyzed, 102 treated with CPAP and 94 treated with NIV. Systolic pulmonary artery pressure decreased from 40.5±1.47 mmHg at baseline to 35.3±1.33 mmHg at 3 years with CPAP and from 41.5±1.56 mmHg to 35.5±1.42 with NIV (p Conclusion: In patients with OHS and concomitant severe OSA, long-term treatment with NIV and CPAP led to similar degrees of improvement in pulmonary hypertension and LVDF.

Rationale: Obesity hypoventilation syndrome (OHS) is commonly treated with noninvasive ventilation (NIV) or CPAP. NIV is more complex and costly but provides ventilatory support. To date there have been no long-term or cost trials comparing these treatment modalities. Methods: We performed a large, randomized, multicenter, open-label controlled trial in Spain to compare the long-term effectiveness of NIV and CPAP using hospitalization days/year-patient as the primary end point. We carried out a simple cost analysis including effectiveness cost during 3 year of follow-up. We included the following cost groups: visits, adjustment of NIV, tests, medication, therapies and hospital resources utilization. A sensitivity analysis was conducted according to 3 different scenarios guided by the International Gross Domestic Product. Results: In total, 215 patients with untreated OHS and severe obstructive sleep apnea (OSA) were randomized to NIV or CPAP therapy and followed at least 3 years. The effectiveness was close between arms (mean difference NIV-CPAP: -0.19, 95% CI -1.13 to 0.75). The cost per patient/year was lower in the CPAP arm (1,898.2€; SD 1939.5) than the cost in the NIV arm (2,809.3€; SD 2901.6), mean difference -911.1€ (p Conclusions: In stable patients with OHS and severe OSA, despite NIV having a slight advantage in effectiveness, CPAP could be considered the first line of treatment due to its lower cost but, a case-by-case assessment is recommended to detect patients who would benefit from a switch to NIV.

Rationale: Obesity hypoventilation syndrome (OHS) is commonly treated with CPAP or noninvasive ventilation (NIV). NIV is more complex and costly but it provides ventilatory support. To date there have been no long-term trials comparing these treatment modalities. Methods: We performed a large, multicenter, open-label controlled trial in Spain to compare the long-term effectiveness of NIV and CPAP: respiratory function, Epworth sleepness scale (ESS), other clinical symptoms, blood pressure (BP) and health related quality of life (HRQL). The analysis was performed according to the intention-to-treat principle. Results: In total, 215 patients with untreated OHS and severe obstructive sleep apnea (OSH) were randomized to NIV or CPAP therapy and followed at least 3 years. PaCO2, bicarbonate and pH improved significantly with both treatments without group differences. FEV1 and FVC improved with positive airway pressure (PAP) but without significant group differences. The 6-MWD test did not improve with either PAP modality and there were no significant group differences. ESS and other clinical symptoms like dyspnea or unrefreshing sleep improved similarly with CPAP and NIV therapy. Both systolic and diastolic BP improved significantly with PAP but without group differences. HRQL tests (SF-36 physical and mental, FOSQ and VAWS) improved with PAP without any significant group differences. Conclusions: In stable patients with OHS and severe OSA, NIV and CPAP have similar long-term effectiveness improving respiratory function, symptoms, BP and HRQL. Given that CPAP has lower complexity and cost, CPAP may be the preferred treatment modality until more studies become available.

Background: Noninvasive ventilation (NIV) and continuous positive airway pressure (CPAP) are the habitual treatments for obesity hypoventilation syndrome (OHS). Despite differences in cost and complexity between them, there are no long-term effectiveness studies comparing both treatments. Objectives: We performed a large multicenter randomized open-labell controlled study to determine the comparative long-term effectiveness of NIV and CPAP using hospitalization days as the primary outcome measure. Methods: Sequentially screened OHS patients with severe sleep apnea were randomized into the above-mentioned arms for at least 3 years of follow-up. Hospital resources utilization, mortality, cardiovascular events incidence, dropouts, compliance and side effects were evaluated. Statistical analysis was performed using intention-to-treat protocol evaluating event/year per patient and incidence by negative binomial, logistic and Cox regressions models and survival analysis. A secundary analysis by compliance subgroups was performed. Results: 215 patients were randomized and 202 were available for primary analysis. The median follow-up was 5.42 years. The hospital days/year was 2.19±5.65 for CPAP and 1.44±3.07 for NIV (adjusted p=0.12). Other hospital resources utilization, cardiovascular events incidence, mortality, dropouts, compliance and side effects were similar between arms. The better compliance subgroup had lower hospital resources utilization and mortality regardless of the treatment used. Conclusion: NIV and CPAP have similar long-term effectiveness. Because CPAP has economical advantages and simplicity, CPAP should be the preferable treatment for OHS patients with severe OSA.

Introduction Home respiratory polygraphy (HRP) is a cost-effectiveness choice to polysomnography (PSG) for diagnosis and treatment in patients with high obstructive sleep apnea (OSA) suspicion what includes 40% of patients needing sleep study. There is not randomized control trial (RCT) focus in the same objective including the entire population needing sleep study (intermediate-high OSA suspicion). Objectives Demonstrate if HRP is a non-inferior effective and a cost-effective alternative to PSG for diagnosis and treatment in most OSA suspicion patients. Method A multicentric, non-inferiority RCT included patients with intermediate-to-high OSA suspicion from 8 centers in Spain. Patients were randomized to be managed (diagnosis and treatment decision-marking) according to PSG or HRP results for 6 months of follow-up. Sleep and quality of life questionnaires, ambulatory 24 hours blood pressure monitoring, CPAP compliance, PSG at 6 months and side effects were collected. An Epworth scale inter-group difference less than -2 in the lower bound of 1-side 95% CI was the non-inferiority premise. QALYS changes were used in a Bayesian cost-effectiveness analysis. Results 430 patients were randomized. At 6 months, changes in the Epworth scale, EuroQol, SF36, FOSQ, analogical scale, PSG and blood pressure were similar between groups. Epworth scale non-inferiority premise was -0.24 adjusted by baseline values and sites. In the cost-effectiveness plane, HRP had similar effectiveness (QALYS different -0.0043) and 421€ lower cost than PSG. Conclusion In this large RCT, HRP was a clear cost-effectiveness alternative to PSG for management of most patients with OSA suspicion. Present results can decrease costs and waiting list across countries.