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临床试验/NCT03567317
NCT03567317已完成不适用

Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Extracellular fluid volume

研究概览

简要总结

The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).

详细描述

Obesity and obstructive sleep apnea share a bidirectional relationship. While obesity is a major risk factor for OSA, OSA may contribute to weight gain. Recent evidence suggests that OSA treatment is associated with weight gain. The mechanisms involved in weight gain after OSA treatment are not known. The purpose of this study is to determine the mechanisms of weight gain during CPAP treatment for severe OSA leads. The investigators hypothesis is that CPAP leads to a decrease in energy expenditure and prevents the elimination of extracellular fluid that is accumulated during the day. In order to test this hypothesis, 20 patients with severe OSA aged between 50 and 80 years old, under regular treatment with CPAP, will be invited to participate. Using a cross-over design, the investigators will perform bioelectric impedance 5 times over 24 hours in order to assess the circadian effect of fluid accumulation in two different conditions: during CPAP treatment and 7 days after CPAP withdrawal. A full polysomnography will be performed during CPAP withdrawal to confirm severe OSA and during CPAP treatment to confirm adequate control of respiratory events. In addition, basal metabolic rate, hematocrit, serum BNP, urinary sodium, creatinine and osmolality will be determined in the morning during the CPAP and CPAP withdrawal periods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of severe OSA (AHI>30 events/h)
  • 50 and 80 years old
  • regular treatment with CPAP with an average daily use of >4hours

排除标准

  • congestive heart failure
  • renal insufficiency
  • hepatic failure
  • urinary incontinency
  • diuretic therapy

结局指标

主要结局

Extracellular fluid volume

时间窗: Seven days

Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.

次要结局

  • Basal metabolic rate(24 hours)
  • Weight change(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Rodrigues Genta

Principal Investigator

University of Sao Paulo General Hospital

研究点 (2)

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