Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 2
- 主要终点
- Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
研究概览
简要总结
The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms.
The study will compare effects of use of high rebound mattress toppers versus use of low rebound mattress toppers on sleep and sleep related symptoms and core body temperature during diagnostic sleep studies.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults Age 18-65 who are scheduled for a diagnostic sleep study at the Stanford Sleep Clinic for sleep disorders (including but not limited to, insomnia, Sleep Apnea or other sleep disorder symptoms).
排除标准
- •Individuals with a history of having difficulty swallowing food or large capsules. We will not be able to enroll individuals with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (IBD), peptic ulcer disease, Crohn's disease, ulcerative colitis, previous gastrointestinal surgery.
- •Individuals who are pregnant.
- •Individuals who are unable to provide informed consent (i.e. decisionally impaired).
结局指标
主要结局
Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
时间窗: Overnight study visit (up to approximately 10hrs)
EEG data collected from the electrode in position C2
Total Sleep Time
时间窗: Overnight study visit (up to approximately 10hrs)
Position Changes Assessed by PSG
时间窗: Overnight study visit (up to approximately 10hrs)
Number of times participant changed position during the sleep recording.
Heart Rate
时间窗: Overnight study visit (up to approximately 10hrs)
Sleep Latency Assessed by PSG
时间窗: Overnight study visit (up to approximately 10hrs)
The amount of time from lights off to falling asleep.
Percentage of Time in Bed During Each Sleep Stage
时间窗: Overnight study visit (up to approximately 10hrs)
Sleep Efficiency Assessed by Polysomnography (PSG)
时间窗: Overnight study visit (up to approximately 10hrs)
Sleep efficiency is total sleep time divided by time in bed. All data were collected through the PSG data that were retrieved from the patients' medical records after completion of the recordings and analysis by the sleep technologists.
Wake After Sleep Onset (WASO) Assessed by PSG
时间窗: Overnight study visit (up to approximately 10hrs)
Total amount of minutes awake after the first sleep epoch.
Apnea Hypopnea Index Assessed by PSG
时间窗: Overnight study visit (up to approximately 10hrs)
The number of apneas or hypopneas recorded during the study per hour of sleep.
Periodic Leg Movements (PLM) During Sleep
时间窗: Overnight study visit (up to approximately 10hrs)
Number of times participant had periodic leg movements during the sleep recording
次要结局
- Visual Analog Scale of Mood(Overnight study visit (up to approximately 10hrs))
- Alliance Sleep Questionnaire (ASQ)(Overnight study visit (up to approximately 10hrs))
- Visual Analog Scale of Sleep(Overnight study visit (up to approximately 10hrs))
- Core Body Temperature(Overnight study visit (up to approximately 10hrs))
- Visual Analog Scale of Performance(Overnight study visit (up to approximately 10hrs))
研究者
Seiji Nishino
Professor, Psychiatry and Behavioral Sciences, Stanford University School of Medicine
Stanford University