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临床试验/NCT01769807
NCT01769807已完成不适用

Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea

University of Lisbon1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2004年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Plasma nitrate (NOx) levels

研究概览

简要总结

Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have been described in severe obstructive sleep apnea (OSA), and are reverted by continuous positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these biomarkers in mild-moderate OSA.

详细描述

The investigators aimed to compare NOx and U-NE levels and blood pressure (BP) between male patients with mild-moderate and severe OSA and determine the impact of 1 month of CPAP therapy on these parameters.

The investigators undertook a prospective study of 67 consecutive OSA patients (36 mild-moderate, 31 severe). Measurements of plasma NOx at 11 pm, 4 am and 7 am, 24-h U-NE and ambulatory BP were obtained at baseline and after 1 month of CPAP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Diagnosis of obstructive sleep apnea

排除标准

  • •current smoker
  • •respiratory disease
  • •cardiac disease (except for arterial hypertension)
  • •renal disorder
  • •hepatic disorder
  • •psychiatric disorder
  • •diabetes mellitus
  • •dyslipidemia
  • •sinusitis
  • •acute illness
  • •daytime hypoxemia or hypercapnia
  • •therapy with oral nitrates
  • •therapy with angiotensin-converting enzyme inhibitors
  • •therapy with beta-blockers
  • •therapy with statins
  • •therapy with non-steroidal anti-inflammatory drugs
  • •presence of central respiratory events
  • •previous CPAP therapy
  • •previous uvulopalatopharyngoplasty

研究组 & 干预措施

CPAP treatment

Experimental

67 consecutive male patients with OSA were recruited: 36 with mild-moderate OSA and 31 with severe OSA. Data were collected in all subjects at baseline and after 1 month of CPAP.

干预措施: CPAP (Device)

结局指标

主要结局

Plasma nitrate (NOx) levels

时间窗: one month

After sleep apnea diagnosis, measurements of plasma NOx at 11 pm, 4 am and 7 am were obtained at baseline and after 1 month of CPAP.

次要结局

  • 24 h Blood pressure(one month after CPAP)
  • Urinary norepinephrine (U-NE) levels(One month)

研究者

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

Paula Pinto

PhD

University of Lisbon

研究点 (1)

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