A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Obstructive Apneas
研究概览
简要总结
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea
- •Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m².
- •Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0 mmol/L within 3 months before the inclusion.
排除标准
- •indication for immediate CPAP
- •other known endocrine disease, except treated and adequately controlled hypothyroidism
- •renal failure or plasma creatinine level >130 µmol/L
- •current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper normal limit (UNL)
- •symptomatic gallbladder disease
- •known muscular disease or creatine phosphokinase (CK) > 3 times UNL.
研究组 & 干预措施
1
Fenofibrate-matching placebo tablet
干预措施: Placebo (Drug)
2
145 mg NanoCrystal fenofibrate tablet
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Obstructive Apneas
时间窗: at one month of treatment
Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).
Desaturations
时间窗: at one month of treatment
Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.
Sleep Time With Oxygen Saturation Below 90%
时间窗: at one month of treatment
Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.
Apneas
时间窗: at one month of treatment
Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment
Hypopneas
时间窗: at one month of treatment
Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.
Index Apnea/Hypopnea
时间窗: at one month of treatment
Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Mixed Apneas
时间窗: at one month of treatment
Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.
Central Apneas
时间窗: at one month of treatment
Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.
Index of Apneas
时间窗: at one month of treatment
Average number of apneas per hour of sleep during one night after one month of treatment.
Index of Hypopneas
时间窗: at one month of treatment
Average number of hypopneas per hour of sleep during one night after one month of treatment.
次要结局
未报告次要终点