cpap effect on lipid profile and hyperuricemia in patients with dyslipidemia and moderate-severe obstructive sleep apnea

Conditions: Sleep Apnea; Dyslipidemias; Hyperuricemia

Summary: clinical trial phase iv indication: moderate-severe obstructive sleep apnea and dyslipidemia. objectives: main objective: to test whether 12 months of cpap treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe osa. secondary objectives: * to test whether 12 months of treatment with cpap associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe osa. * to determine the additional medium- and long-term effect of cpap on insulin resistance in patients with dyslipidemia and moderate-severe osa. * to evaluate the impact of cpap treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe osa. * to analyze the impact of supplemental cpap treatment on glycemic control and c-reactive protein concentration in patients with dyslipidemia and moderate-severe osa. * to establish the impact of supplemental cpap therapy on health-related quality of life in patients with dyslipidemia and moderate-severe osa. * to evaluate the effect of cpap on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe osa. * to relate cpap-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones. * to identify the subgroup of patients with dyslipidemia and moderate-severe osa in whom 12 months of cpap treatment achieves a more marked reduction in serum lipids and uric acid. design randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment. study population subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (osa) not requiring cpap treatment according to conventional indications. sample size: 110 patients in each treatment arm. treatment patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms: 1. conventional hygienic-dietary recommendations and promotion of daily physical activity. 2. conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (cpap). efficiency variables * main variables: ldl-cholesterol and uric acid. * total cholesterol, hdl-cholesterol and triglycerides. * basal blood glucose, glycosylated hemoglobin (hba1c), creatinine and c-reactive protein. * systemic biomarkers: inflammatory (il-6, il-8 and tnf-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vcam-1 and icam-1), sympathetic activity (neuropeptide y) and appetite-regulating hormones (leptin, orexin a/hypocretin 1 and ghrelin). * clinical questionnaires: sf-12, euroqol, fosq and ipaq. safety variables * clinical adverse event reporting. * cpap compliance (average hours of use per day). * epworth sleepiness questionnaire. * development of cardiovascular events.


Eligibility criteria:
inclusion criteria: * subjects from 35 to 80 years old * diagnosis of dyslipidemia. it will be considered as such, the existence of a previous clinical record of a diagnosis of dyslipidemia associated with treatment with lipidlowering agents, treatment with lipid-lowering agents or the presence of an altered blood test in the last two months, using the following cut-off points: total cholesterol ≥ 200 mg/dl, triglycerides ≥ 180 mg/dl, hdl-cholesterol ≤ 40 mg/dl or ldl-cholesterol ≥ 150 mg/dl. * moderate-severe sleep apnea, defined by ahi \> 15 h-1 . exclusion criteria: * predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events. * patients with indications for cpap treatment according to the international sleep consensus: hypertensive, excessive daytime sleepiness (epworth sleepiness scale \> 11) or impaired sleep-related quality of life considered relevant by their regular physician. * professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing). * pretreatment with cpap