Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure
研究概览
简要总结
The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.
The main question it aims to answer is:
Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?
详细描述
The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.
The main question it aims to answer is:
Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?
Participants will:
- Take melatonin or the habitual treatment every day for one month
- Visit the clinic 11 times for one month
- Keep a diary of their symptom and activities and use twice a 24 h ambulatory blood pressure monitoring (ABPM), attend two overnight polysomnography studies, and use an actigraph every day for 2 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polisomnographic diagnosis of Obstructive Sleep Apnea
- •Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):
排除标准
- •Use of sleep or psychiatric medication
- •Use of Positive Airway Pressure (CPAP or Bipap)
- •Neurologic or psychiatric disorder
研究组 & 干预措施
Usual care for nocturnal non-dipping Blood Pressurem in OSA
1. Group of participants receives an intervention/treatment considered to be usual care
干预措施: Melatonin 3 MG Oral Tablet (Drug)
Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA
2. Group of participants receives oral Melatonin 3 mg/day during 30 days plus usual care
干预措施: Melatonin 3 MG Oral Tablet (Drug)
结局指标
主要结局
Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure
时间窗: 30 days
Wake after sleep onset (WASO) and non-dipper patter of Blood Pressure change after melatonin intake for 30 days
次要结局
未报告次要终点
研究者
Matilde Valencia-Flores
Coordinator/ Head of the Sleep Disorders Clinic
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran