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临床试验/NCT05253963
NCT05253963已完成不适用

Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年9月29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
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

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

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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