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临床试验/NCT00669513
NCT00669513已完成3 期

Cardiovascular Effects of Partial Sleep Deprivation in Healthy Volunteers

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
15
试验地点
2
主要终点
Venous endothelial function

研究概览

简要总结

Background: Sleep curtailment is common and is associated with increased mortality due to cardiovascular causes. However, the mechanisms are not completely understood.We hypothesized that partial sleep deprivation caused however significant changes in sympathetic activity and endothelial function in healthy volunteers.

Methods: Thirteen young healthy male volunteers will be monitored during 12 days by sleep diary and wrist actigraphy. The subjects will keep under their usual daily activities and randomized to 5 nights of prolonged sleep (control) or partial sleep deprivation, interposed by 2 nights of unrestricted sleep (wash out). At the end of each period, the subjects will be evaluate by: 1. electrocardiogram and beat-to-beat blood pressure with spectral analysis of heart rate and blood pressure in the supine position and after head up tilt test maneuver; 2. resting plasma norepinephrine; 3. venous endothelial function (dorsal hand vein technique).

详细描述

Volunteers Healthy young male volunteers from the urban area of Sao Paulo city will be recruited to the study. All subjects will be clinically evaluated, including measurements of weight and height. Exclusion criteria include age less than 21 and more than 45 years, body mass index (BMI) >25 kg/m2, smoking, use of chronic medications and any established medical condition including diabetes mellitus, hypertension, dyslipidemia, heart diseases and sleep disordered breathing. After obtaining written informed consent, all participants will be submitted to overnight polysomnography.

Polysomnography Overnight polysomnography will be performed to discarded sleep breathing using a digital system (17 channels, EMBLA Medicare - Flaga hf. Medical Devices). All polysomnograms will be performed and scored based on the guidelines for sleep studies. The apnea-hypopnoea index (AHI) was defined by the number of apneas and hypopnoeas per hour of sleep. Sleep disordered breathing was defined by an AHI above 5 events/hour, according to standard criteria.

Sleep Monitoring During the study period all subjects will be continuously monitored by a sleep diary and wrist actigraphy (Basic Mini Motionlogger Actigraph Ambulatory Monitoring, Inc., Ardsley , New York, USA ) worn on the non-dominant hand. The actigraph will set to sample movements in 1 min periods. Actigraph records will automatically process by use of the AW2 software version 2.3.01 program (Ambulatory Monitoring, Inc.) to extract information on sleep duration.

Blood Samples Venous blood will be collected from all participants between 8 and 10 AM for the measurement of glucose, total cholesterol, low-density lipoprotein, high-density lipoprotein, and red blood cell count. Plasma catecholamine (norepinephrine) will be measured by High-Performance Liquid Chromatography.

Hemodynamic and autonomic measurements Hemodynamic and autonomic evaluations will be performed in the morning between 8 and 10 AM. The intervals between adjacent QRS complexes resulting from sinus node depolarization will be determined (RR intervals). Heart rate will be calculated by expressing RR intervals as beats per minute. Non-invasive beat-to-beat blood pressure (Finometer, Finapres Medical System BV, Holland) and electrocardiogram (ECG) will be continuously recorded by the software AT/MCA-CODAS (DATAC Instruments Inc., Akron, Ohio, EUA). The sampling rate was 1000 Hz per channel.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy young male volunteers from the urban area of Sao Paulo city

排除标准

  • Age less than 21 and more than 45 years
  • Body mass index (BMI) >25 kg/m2
  • Use of chronic medications and any established medical condition including
  • diabetes mellitus
  • hypertension
  • dyslipidemia
  • heart diseases and
  • sleep disordered breathing

结局指标

主要结局

Venous endothelial function

次要结局

  • Inflammation
  • Sympathetic activity

研究者

申办方类型
Other

研究点 (2)

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