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临床试验/NCT02945254
NCT02945254已完成1 期

Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Sleep Onset Latency (Mins)

研究概览

简要总结

Insufficient and low-quality sleep is a major public health problem that has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity.

The number of people using sleep-inducing drugs to increase or improve sleep is steadily increasing in the last few decades; however, the side effects of these therapies often outweigh the benefits.

A few small trials and anecdotal findings suggest that continuous background (pink or white) noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency.

In an attempt to find new, alternative solutions to increase sleep quality in people suffering from insomnia, the investigators would like to test the effect of surrounding filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.

研究设计

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

入排标准

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

入选标准

  • Age between 21 and 60

排除标准

  • Any sleep disorder
  • Use of hypnotics

研究组 & 干预措施

Background noise

Active Comparator

Overnight sleep study with filtered white noise

干预措施: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) (Device)

Silence

No Intervention

Overnight sleep study with normal environmental noise

结局指标

主要结局

Sleep Onset Latency (Mins)

时间窗: 1 night

time from lights out to the first epoch of stage 2 NREM sleep

次要结局

  • Subjective Sleep Quality (VAS)(1 night)

研究者

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

David Andrew Wellman

MD, PhD

Brigham and Women's Hospital

研究点 (2)

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