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临床试验/NCT01853891
NCT01853891撤回不适用

Effects of Sleeping With Dim Light at Night in Patients With Obstructive Sleep Apnea

Ulysses Magalang MD2 个研究点 分布在 1 个国家开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Exposure to Dim Light at Night

研究概览

简要总结

With the advent of electricity, light at night has become a ubiquitous part of our society.

The main purpose of this study is to determine whether sleeping with dim light (40 lux), the brightness of a night light) in your bedroom for 5 consecutive nights will result in increased markers of inflammation in the blood compared to sleeping in darkness during the night in patients with obstructive sleep apnea (OSA).

A secondary aim is to examine the effects on insulin sensitivity, other blood proteins, and RNA molecules as a result of sleeping with dim light. RNA molecules are substances in blood that dictate what type of proteins the body should make.

详细描述

The primary objective of this study is to determine whether sleeping with dLAN (40 lux) for 5 consecutive nights will result in increased markers of inflammation compared to sleeping in darkness (< 1 lux) during the night in patients with OSA. A secondary aim is to examine the effects on insulin sensitivity, adipokines, and RNA molecules.

The risks associated with this study are minimal compared to the potential benefits. Knowledge about the effects of sleeping with dim light on inflammation in patients with OSA is important and would guide future recommendations about proper sleep hygiene. This research may also guide future recommendations about light conditions in other environments such as hospital bedrooms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • • 18 -60 years of age.
  • Willing and able to give informed consent
  • AHI >10 episodes per hour based on a prior PSG.
  • Patients who have been started on treatment for OSA with either Continuous Positive Airway Pressure (CPAP) or dental device will be eligible for the study as long as they have been compliant with treatment for at least 30 days.

排除标准

  • • Incapable of giving informed consent
  • Under the age of 18
  • Currently sleeping with lights on in the bedroom
  • Excessive alcohol consumption
  • Excessive alcohol use is defined as:
  • More than 3 glasses of wine a day
  • More than 3 beers a day
  • More than 60 mL of hard liquor a day
  • Room air oxyhemoglobin saturation < 88%
  • Use of home oxygen
  • Use of corticosteroids and other immunosuppressive medications.
  • Diagnosis of: HIV, Connective Tissue Disease (Lupus, Rheumatoid arthritis), Inflammatory Bowel Disease.

结局指标

主要结局

Exposure to Dim Light at Night

时间窗: 5 consecutive nights

The main purpose of this study is to determine whether sleeping with dim light (40 lux), the brightness of a night light) in your bedroom for 5 consecutive nights will result in increased markers of inflammation in the blood compared to sleeping in darkness during the night in patients with obstructive sleep apnea (OSA).

次要结局

未报告次要终点

研究者

发起方
Ulysses Magalang MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ulysses Magalang MD

Professor

Ohio State University

研究点 (2)

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