Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
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
- 是
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
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
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
David Andrew Wellman
MD, PhD
Brigham and Women's Hospital
