GESAP trial rationale and methodology: management of patients with suspected obstructive sleep apnea in primary care units compared to sleep units

摘要

BACKGROUND Obstructive sleep apnea syndrome (OSA) is a chronic sleep disorder characterized by repeated episodes of upper airway collapse during sleep. This leads to arterial hypoxemia and sleep disruption and causes daytime sleepiness and several associated dysfunctions, including cardiovascular, respiratory, metabolic, inflammatory, cognitive, and behavioral disorders.(1) OSA is a relevant public health issue, with epidemiological studies showing a prevalence of 10% in middle-aged men and 3% in middle-aged women.(2) Moreover, OSA has been associated with the development of cardiovascular events(3,4) and resistant hypertension,(5) has a negative impact on quality of life,(6) and has even been shown to have a causative role in traffic accidents.(7) The application of continuous positive airway pressure (CPAP) is a highly effective treatment for OSA that can improve symptoms and quality of life, decrease traffic accidents and potentially lessen cardiovascular morbidity.(8,9) Furthermore, CPAP is cost-effective.(10) However, only approximately 10% of individuals with OSA are diagnosed and treated. This scarcity in diagnosis has direct public health consequences due to the above-mentioned health implications and the high economic costs associated with untreated OSA. Currently, the diagnosis and management of OSA are performed in highly specialized hospital-based sleep units (SUs), where full sleep studies (polysomnography (PSG)) or respiratory poligraphy (RP) can be conducted. However, this management approach has proven to be insufficient in identifying most OSA cases in the population, in addition to being cost-ineffective and generating long waiting lists.(11) Given that OSA is a common chronic disorder, we believe that all levels of a healthcare system, especially primary care (PC), should be included in its management.(12-14) The first trials assessing the management of OSA at the PC level reported satisfactory results.(15-19) Moreover, our group showed that CPAP compliance did not differ between the PC and SU setting and was more cost-effective in the PC setting. 19 However, in the above studies, although OSA management occurred at the PC level, diagnosis had always occurred in a SU. Therefore, in the current study, we aimed to determine the efficacy and cost-effectiveness of implementing a program for the diagnosis and management of OSA that can be conducted by PC personnel, and we compared these outcomes to those generated using the standard diagnosis and management protocols that are practiced in SUs. AIMS The main objectives of the GESAP study are to assess the efficacies of PC and SU programs for OSA management. These assessments will be made using the Epworth sleepiness scale (ESS) before and for 6 months after initiating the program to assess its cost-effectiveness based on both ESS and quality of life (EuroQol-5D). Secondary objectives include assessments of patient satisfaction, treatment compliance, and the number, severity, and evolution of the treatment's side effects.