WithdrawnNot Applicable

Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea

Stopped: Limitations to recruitment related to COVID

Spain0Started 2015-05

Plain-language summary

OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA). Secondary objectives: * Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA. * Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA. DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment. STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels\> 100 mg / dl in the last two successive visits clinics. Sample size. 38 patients who completed the test in each treatment arm. TREATMENT Patients will be randomized to one of the following treatment arms form: 1. hygiene and dietary recommendations. 2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control). 3. Treatment with positive airway pressure (CPAP). ENDPOINTS: Efficacy endpoints. * Primary endpoint: LDL-cholesterol. * Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP). * Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin). * Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH). * Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ). Security endpoints. * Notification of clinical adverse events. * Compliance with CPAP (average hours use per day). * Epworth Sleepiness Questionnaire. * Development of cardiovascular events.

Who can participate

Age range35 Years – 75 Years

SexALL

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Inclusion Criteria: * Diagnosis of dyslipidemia: The existence of a previous clinical diagnostic of dyslipidemia associated with lipid-lowering therapy. It is also considered patients who have an altered analytical, using the following cutoffs: total cholesterol ≥ 200 mg / dl, triglycerides ≥ 180 mg / dl, HDL-cholesterol ≤ 40 mg / dl or LDL-cholesterol ≥ 150 mg / dl. Lipid-lowering treatment and diet, stable in the last month. * A concentration of LDL-cholesterol above 100 mg / dl, in the month prior to inclusion. * An apnea-hypopnea index between 5-30 h-1 Exclusion Criteria: * Apnea-hypopnea index of less than 5 h-1 or greater than 30 h-1. * Predominance of central apneas and hypopneas, defined as more than 25% of all respiratory events. * Professional drivers, risk profession or respiratory failure (according to criteria of the clinical pathway for diagnosis and treatment of sleep-disordered breathing). * Very excessive daytime sleepiness (Epworth Sleepiness Scale\> 18). * Morbid obesity (BMI\> 40 kg / m2). * Prior treatment with CPAP.

What they're measuring

LDL-cholesterol

Timeframe: 6 months

Trial details

NCT IDNCT02557412

SponsorHospital Universitario La Paz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12