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.
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 .
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
Parallel
Continuous positive airway pressure
DeviceTreatment will start with an empirical pressure of 8 cmH2O and, within a maximum of 3 weeks, the pressure will be adjusted by means of automatic titration, establishing the pressure corresponding to the 95th percentile.
Hygienic-dietary recommendations and daily physical activity promotion
Other interventionHygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated.
CPAP effect on lipid profile
Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups
CPAP effect on lipid profile-2
Comparison of 12-months change from baseline in the plasma level of HDL-cholesterol between the two study groups
CPAP effect on lipid profile-3
Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups
CPAP effect on lipid profile-4
Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups
CPAP effect on uric acid
Comparison of 12-months change from baseline in the plasma level of uric acid between the two study groups
Medium-term CPAP effect on insulin resistance
Comparison of 6-months change from baseline in the HOMA index between the two study groups
Long-term CPAP effect on insulin resistance
Comparison of 12-months change from baseline in the HOMA index between the two study groups
CPAP effect on cardiovascular risk
Comparison of 12-months change from baseline in the cardiovascular risk score between the two study groups
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Hospital Universitario La Paz
Lead sponsor
Hospital Universitario del Henares
Collaborator
