Primary Care Physicians Can Comprehensively Manage Sleep Apnea Patients using a semi-automatic algorithm

Rationale: The passive role of general practitioners in obstructive sleep apnea (OSA) management could change with a simplify diagnosis and a semi-automatic algorithm for treatment, wich has cost advantages. Objective: To determine differences in effectiveness between primary healthcare area (PHA) and in-laboratory (IL) specialized management protocols with six months of follow-up. Methods: A multicenter, non-inferiority, randomized, controlled trial with two open parallel arms and cost-effectiveness analysis was performed. Patients with an intermediate to high OSA probability (50% of patients with a low to high OSA suspicion) were randomized to both protocols. The PHA arm involved a portable monitor with automatic scoring and semi-automatic therapeutic decision-making. The IL arm included polysomnography and specialized therapeutic decision-making. The primary outcome measure was the Epworth sleepness scale (ESS). Secondary outcomes were health-related quality of life, blood pressure, incidence of cardiovascular events, hospital resource utilization, continuous positive airway pressure adherence and within-trial costs. Results: In total, 307 patients were randomized and 303 were included in the intention-to-treat analysis. Based on the ESS, the PHA protocol was non-inferior to the IL protocol. Secondary outcome variables were similar between protocols. The cost-effectiveness relationship favored the PHA arm, with a lower cost of 537.8€ per patient. Conclusion: PHA management may be an alternative to IL management for approximately half of patients with a low to high OSA suspicion. Given the clear economic advantage, this finding could change established clinical practice.