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临床试验/NCT03492736
NCT03492736终止1 期

Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?

Naomi Deacon1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
PHQ-9 score

研究概览

简要总结

The investigators have previously shown that 1 week of 10mg Melatonin improves sleep consolidation in untreated obstructive sleep apnea (OSA) patients. This study aims to extend on those findings to determine if longer treatment of Melatonin improves other outcomes in untreated OSA patients.

详细描述

Intermittent hypoxia (low oxygen), sleep fragmentation and restriction are characteristic of obstructive sleep apnea (OSA) and cause mental deficits and cardiovascular disease (CVD). Melatonin (MLT) is a hormone with sleep promoting properties and the investigators have found 7 days 10mg MLT treatment significantly increases sleep consolidation in untreated OSA. Thus, melatonin could improve mental function. MLT also has potent antioxidant, anti-inflammatory and anti-hypertensive properties. In humans with CVD and metabolic disorder exogenous MLT improves a wide range of cardio-metabolic outcomes. In rat models of OSA, MLT completely blocks intermittent hypoxia induced cardiovascular damage and brain cell death. Intermittent hypoxia also induces lasting changes in the neural control of breathing, which worsens OSA. Experimentally antioxidants block the induction of changes to neural control of breathing. Thus MLT may also normalize the control of breathing and reduce the severity of OSA. Given these findings, the hypothesis is that MLT will improve mental function, cardiovascular outcomes and control of breathing in untreated OSA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •moderate-severe OSA (AHI ≥15/hr)

排除标准

  • •non-English speakers (due to necessity to complete neurocognitive testing)
  • •other sleep disorders
  • •history of driving or other accidents due to sleepiness or an Epworth score (ESS)> 18
  • •smokers (quit ≥ 1 year ago acceptable)
  • •cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease
  • •Substantial alcohol (>3oz/day) or use of illicit drugs
  • •psychiatric disorders (other than depression or anxiety)
  • •current MLT use or use within last 6 months
  • •beta blockers, central nervous system depressants or stimulants, anti-inflammatories, anticoagulants, immunosuppressants, vitamins, antioxidants.

研究组 & 干预措施

Placebo

Placebo Comparator

30 days placebo taken nightly 1 hour before bed

干预措施: Placebo (Other)

Melatonin

Experimental

30 days 10mg Melatonin taken nightly 1 hour before bed

干预措施: Melatonin (Dietary Supplement)

结局指标

主要结局

PHQ-9 score

时间窗: baseline versus on the 30th day of treatment

9 Questions relating to depressive symptoms. Answers to each question rank from 0-3. Minimum total score = 0, maximum total score = 27, with \>=10 indicating clinically significant moderate severity depressive symptoms.

次要结局

  • Reactive Hyperemia Index(baseline versus on the 30th day of treatment)

研究者

发起方
Naomi Deacon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Naomi Deacon

Research Scholar

University of California, San Diego

研究点 (1)

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