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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- CPAP effect on lipid profile-4
研究概览
简要总结
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:
- Conventional hygienic-dietary recommendations and promotion of daily physical activity.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 .
排除标准
- •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
结局指标
主要结局
CPAP effect on lipid profile-4
时间窗: 12 months
Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups
CPAP effect on lipid profile
时间窗: 12 months
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
时间窗: 12 months
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
时间窗: 12 months
Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups
次要结局
- Long-term CPAP effect on insulin resistance(12 months)
- CPAP effect on cardiovascular risk(12 months)
- CPAP effect on uric acid(12 months)
- Medium-term CPAP effect on insulin resistance(6 months)
- CPAP effect on health-related quality of life-2(12 months)
- CPAP effect on health-related quality of life(12 months)
- CPAP effect on daily physical activity(12 months)
- CPAP effect on inflammatory cytokines(12 months)
- CPAP effect on oxidative stress biomarkers(12 months)
- CPAP effect on glycemic control(12 months)
- CPAP effect on C-reactive protein(12 months)
- CPAP effect on sleepiness(12 months)
- CPAP effect on intake-regulating hormones(12 months)
- CPAP effect on sympathetic tone(12 months)
研究者
Francisco Garcia-Rio
PhD
Hospital Universitario La Paz