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临床试验/NCT00238108
NCT00238108已完成2 期

Melatonin Supplementation in Hypertensive Patients

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Sleep Quality

研究概览

简要总结

This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.

详细描述

Hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. It is estimated that one in three individuals in the United States has high blood pressure, though many do not know it because there are usually no symptoms. Uncontrolled hypertension may lead to stroke, heart attack, heart failure, or kidney failure. Beta-blockers are one class of drugs that have been developed to help lower blood pressure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Many individuals who take beta-blockers for hypertension complain that they have trouble sleeping, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in lowering blood pressure.

Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. Participants will take part in two inpatient phases. Each inpatient stay will last 4 days and will be separated by 3 to 4 weeks. While in the clinic, participants' sleep patterns and core temperature will be recorded and plasma, saliva, and urine samples will be collected. Blood pressure will be measured before and after each inpatient stay, as well as at points during the stay. Throughout the study, participants' activity will be monitored by an accelerometer worn around the wrist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with uncomplicated hypertension
  • Currently being treated with Atenolol (a beta-blocker)

排除标准

  • History of medical illness other than essential hypertension
  • Personal or family history of psychiatric illness
  • Current use of any medication other than anti-hypertensive drugs
  • Any recent travel across time zones
  • History of working various shifts on an irregular basis

研究组 & 干预措施

1

Experimental

Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks)

干预措施: Melatonin (Drug)

2

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Sleep Quality

时间窗: Measurement after 3 weeks of supplementation

Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)

次要结局

  • Change in Systolic Blood Pressure(Measurement after 3 weeks of supplementation compared to baseline)

研究者

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

Frank AJL Scheer, PhD

Assistant Professor of Medicine

Brigham and Women's Hospital

研究点 (1)

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