Abstract
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.
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