CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea

Официальное название

Effect of 12 Months of Treatment With Continuous Positive Airway Pressure on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea. A Randomized, Open-labell, Parallel Clinical Trial

Обзор

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.

Вмешательства

• Устройство Continuous positive airway pressure
  Treatment 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.
• Другое Hygienic-dietary recommendations and daily physical activity promotion
  Hygienic-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.

Первичные конечные точки

• CPAP effect on lipid profile [Срок оценки: 12 months]
• CPAP effect on lipid profile-2 [Срок оценки: 12 months]
• CPAP effect on lipid profile-3 [Срок оценки: 12 months]
• CPAP effect on lipid profile-4 [Срок оценки: 12 months]

Вторичные конечные точки (12)

• CPAP effect on uric acid [Срок оценки: 12 months]
• Medium-term CPAP effect on insulin resistance [Срок оценки: 6 months]
• Long-term CPAP effect on insulin resistance [Срок оценки: 12 months]
• CPAP effect on cardiovascular risk [Срок оценки: 12 months]
• CPAP effect on glycemic control [Срок оценки: 12 months]
• CPAP effect on C-reactive protein [Срок оценки: 12 months]
• CPAP effect on sleepiness [Срок оценки: 12 months]
• CPAP effect on health-related quality of life [Срок оценки: 12 months]
• CPAP effect on health-related quality of life-2 [Срок оценки: 12 months]
• CPAP effect on daily physical activity [Срок оценки: 12 months]
• CPAP effect on inflammatory cytokines [Срок оценки: 12 months]
• CPAP effect on oxidative stress biomarkers [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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 .

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario del Henares — Coslada

Идентификаторы

NCT: NCT06463561 · 082024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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