Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
The effect of CPAP on weight and fluid homeostasis will be assessed. Obstructive sleep apnea treatment-naive subjects will randomized to CPAP and control groups. Weight change, and changes in overnight urinary volume, intra and extracelullar volume, plasmatic B-type natriuretic peptide (BNP) and antidiuretic hormone (ADH) and urinary osmolality will be compared between groups.
详细描述
There is a bidirectional relationship between Obstructive Sleep Apnea (OSA) and obesity. Although obesity can lead to OSA, patients with OSA are more likely to gain weight. The mechanisms that lead to weight gain during the treatment of OSA are not known. Some evidence supports the hypothesis that fluid accumulation could be a possible explanation for weight gain after treatment for OSA. The hypothesis is that one night of CPAP treatment promotes increased body weight and reduced diuresis in patients with OSA. Participants will be submitted to 2 consecutive nights of polysomnography (PSG). A baseline PSG will be performed during the first study visit. During the second study night, participants will be randomized into two groups, CPAP and control (repeat baseline PSG). Overnight urinary volume will be determined. Intra and extracellular water volume will be assessed using electrical bioimpedance before bedtime and just after the subject wakes up. Plasmatic BNP and ADH and urinary osmolality will also be determined during each morning following PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a diagnosis of Obstructive Apnea Sleep
- •Over 18 years of age
- •No previous treatment with Continuous Positive Airway Pressure
排除标准
- •Congestive heart failure
- •Renal insufficiency
- •Hepatic failure
- •Urinary incontinency
- •Diuretic therapy
结局指标
主要结局
Weight change
时间窗: After 6 hours of Continuous Positive Airway Pressure treatment
Weight change with just one night of CPAP treatment.
Diuresis change
时间窗: After 6 hours of Continuous Positive Airway Pressure treatment
diuresis change with just one night of CPAP treatment.
次要结局
- Intra and extracellular fluid volume(Before the beginning and after 10 hours of the nocturnal polysomnography.)
- Urinary osmolarity(After 10 hours of the nocturnal polysomnography)
- Atrial natriuretic peptide and antidiuretic hormone(After 10 hours of the nocturnal polysomnography)
研究者
Pedro Rodrigues Genta
Principal Investigator
University of Sao Paulo General Hospital
