The Effect of White Noise In High Noise Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sleep Latency data using the actigraph
研究概览
简要总结
Many patients complain to clinicians that they have difficulty sleeping appears to be due to environmental noise. There is a common perception that acute noises are more troublesome than continuous noises in the effect on individual sleep quality. Therefore the goal is to use a Marpac white noise maker with a continuous noise to see its effect on individuals that have difficulty sleeping in a high noise environment.
详细描述
Insomnia patients will be recruited based on their perception of high noise in their apartment. The investigators will screen patients during the first meeting using The Mini International Neuropsychiatric Interview 6.0 (MINI 6.0). At baseline, an Insomnia Severity Index will be administered.
The study will consist of a one week baseline period in which noise levels will be monitored using spectral analysis and decibel levels and sleep duration will be recorded using a subjective sleep log and wrist actigraphy for objective measurement. At the end of the first week an Insomnia Severity Index will be administered.
During the second week, a treatment period with a white noise machine using a fixed decibel level will be installed in the bedrooms of the subjects. The room noise will continue to be monitored via spectral analysis as well as decibel levels while the patients are wearing actigraphs and keeping a sleep log. At the end of the second week an Insomnia Severity Index will be administered.
During the third week, the white noise machine will be removed and the rooms will still be monitored for sound via spectral analysis and decibel levels and the subject will wear an actigraph and keep a sleep log. At the end of the third week an Insomnia Severity Index will be administered.
The investigators will use Analysis of Covariance (ANCOVA) with baseline vs. white noise to analyze differences. The investigators will use an Acute Noise Index, in which noise spikes of 2 standard deviations from the mean of the entire nights decibel levels count as a noise event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for each participant are as follows: Must be between 18 and 100 years old
- •No significant psychiatric conditions based on the The Mini International Neuropsychiatric Interview 6.0 (MINI 6.0)
- •Not currently using narcotics, psychotropic or hypnotic medications and willing to refrain from using these medications during the course of the study
- •Limits caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day before 12 noon
- •Limits alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night
- •Must adjust alcohol consumption to 7-drinks per week and less than or equal to 1 drink on any one night for at least two weeks before study begins, and must not consume alcohol later than 8pm
- •Naps less than or equal to 1-hour per week according to subjective report
- •For at least 3 times a week a minimum of 30 minute sleep latency or 30 minutes of total nighttime awakening due to subjective elevated noise.
排除标准
- •Exclusion criteria for each participant are as follows: Younger than 18 years old or older than 100 years old
- •Significant psychiatric conditions based on the The Mini International Neuropsychiatric Interview 6.0 (MINI 6.0)
- •Currently using narcotics, psychotropic or hypnotic medications and not willing to refrain from using these medications during the course of the study
- •Does not limit caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day
- •Does not limit alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night , consumes alcohol later than 8pm
- •Naps more than 1-hour per week according to subjective report
- •Not at least 3 times a week at least 30 minute sleep latency or not 30 minutes of total nighttime awakening due to subjective elevated noise
研究组 & 干预措施
White Noise
Subject will have white noise machine placed in room.
干预措施: white noise (Other)
结局指标
主要结局
Sleep Latency data using the actigraph
时间窗: Three weeks
Subjects will have three weeks of sleep latency data using the actigraph and this data will be analyzed and presented.
次要结局
- Sleep Latency data using sleep diaries(Three Weeks)
- Insomnia Severity Index(Three Weeks)