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临床试验/NCT01865864
NCT01865864终止不适用

Changes In Diurnal Blood Pressure Pattern In Obstructive Sleep Apnea (OSA) Patients After CPAP Therapy

Northwell Health1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
drop of Blood pressure at night

研究概览

简要总结

to test whether using CPAP can restore the normal pattern of drop of blood pressure during sleep.

详细描述

OBJECTIVE:

To investigate the effect of CPAP therapy on the restoration of the normal diurnal blood pressure pattern. Possible improvement of the circadian dipper pattern after CPAP therapy, with or without a decrease in the mean blood pressure, might constitute an additional potential benefit of CPAP therapy in reducing cardiovascular risk in patients with OSA.

STUDY DESIGN AND METHODS:

Patients diagnosed with OSA at the sleep center will undergo blood pressure monitoring by measuring the blood pressure every half hour during sleep study. Patients with normal circadian BP changes are treated with CPAP as indicated. Patients with non-dipping BP pattern will be approach to join our study. The patients will receive CPAP therapy. The trial period will be 6 weeks. At the end of the trial, the patients from both treatment arms will undergo a second BP monitoring according to our above-mentioned protocol (systolic, diastolic and mean BP) to determine the circadian BP changes. Apnea-Hypopnea index will be calculated to reflect on the compliance with our therapy. Thus, patients could be divided into two study groups according to their objective compliance.

Baseline population characteristics between the placebo group and CPAP group will be noted. These include apnea-hypopnea index (AHI), medications, other co morbidities and other factors that might affect the normal circadian BP dipping pattern including factors affecting the volume status i.e. diabetes, renal failure, uncontrolled diabetes. Any new medications added during the 6 weeks trial period will be noted.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • All patients with OSA who don't meet the above mentioned exclusion criteria

排除标准

  • Patients who have a normal diurnal sleep pattern (i.e. decrease of more than 30% of the systolic BP at night time)
  • Patients who are on three or more antihypertensives whose blood pressure is not controlled.
  • Patients previously treated with CPAP therapy within the past 3 months

结局指标

主要结局

drop of Blood pressure at night

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

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

Suzanne El-Sayegh

M.D.

Northwell Health

研究点 (1)

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