The Effect of Sodium-Restricted Diet and Diuretic in the Severe Sleep Apnea: a Randomized Controlled Trial - DESALT Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index
研究概览
简要总结
This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or 3) placebo pill in the treatment of obstructive sleep apnea in adults.
详细描述
Men with apnea-hypopnea index greater than 30/hour will be included and randomly assigned into three groups: sodium-restricted diet, or diuretic, or control. The intervention will last one week. The diuretic group will receive combined spironolactone 100mg plus furosemide 20mg daily. The diet group will receive a regimen with a maximum intake of three grams of sodium per day. The control group will receive a placebo pill and will maintain all eating habits.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men in the age range from 18 to 60 years
- •Full-night in-laboratory polysomnography with apnea-hypopnea index > 30/h in the last three months
- •Body mass index < 35 kg/m2
- •Informed consent
排除标准
- •Already having started any treatment for sleep apnea, including use of continuous positive airway pressure
- •NYHA heart failure, any class
- •Predominantly central apnea
- •Peripheral venous or lymphatic insufficiency
- •Any chronic renal disease
- •Use of diuretics and substances with action in the central or peripheral nervous system such as benzodiazepines, hypnotics, anticonvulsants, antidepressants, appetite suppressants, amphetamines, antiparkinson agents, muscle relaxants, bronchodilators
- •Stroke within 6 months or with incapacitating sequelae
- •Any physical, mental or social condition impairing the ability to participate in the trial
研究组 & 干预措施
Lasilactone
Dosage form: One capsule taking in the morning Dosage: furosemide, 20mg, and spironolactone, 100 mg. Frequency and duration: One capsule daily for 7 days.
干预措施: Lasilactone (Drug)
placebo pill
One capsule taking in the morning. Frequency and duration: One capsule daily for 7 days.
干预措施: Placebo (Drug)
Sodium-Restricted Diet
The diet group will receive a regimen with a prescribed intake of three grams of sodium per day
干预措施: Sodium-Restricted Diet (Other)
结局指标
主要结局
Apnea-Hypopnea Index
时间窗: One week
Number of apneas/hour
次要结局
- Somnolence scale (Epworth) and ventilatory parameters(One week)
- Dosages of urinary 24h(One week)
- Glycolipid profile(One week)
- Aldosterone Renin Level Activity(One week)
- Inflammatory marker(One week)