Double Blind, Placebo Controlled, Crossover Pilot Trial on the Effect of Optically Modified Polyethylene Terephthalate Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).
研究概览
简要总结
Sleep quantity and quality can be influenced by the type of mattress used. This study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep quality.
详细描述
It is commonly observed that sleep in its quantity and quality is influenced by the type of mattress used at night. A recent study in patients with back pain showed that waterbeds and foam mattresses did influence back symptoms, function and sleep more positively than did a hard mattress. Pain improves with airbeds compared to regular innerspring mattresses. This study will analyze the effect of optically active particles mattress covers on sleep. The researcher is interested in learning if regular mattress or the study mattress cover (containing optically modified polyethylene terephthalate fiber mattress cover) is more useful in helping back pain and sleep quality.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You are eligible to participate in this study if you:
- •have a clinical diagnosis of chronic lower back pain
- •have pain measured on the Visual Analogue scale
- •have sleep disturbances at night associated with chronic lower back pain
- •are 18 years or older
- •sign the written, informed consent form prior to the initiation of any study procedures
- •have an habitual bedtime between 8 P.M. and 12 A.M.
- •are on a stable pain management regime
排除标准
- •You are not eligible to participate in this study if you:
- •are unwilling or unable to comply with the protocol or scheduled appointments
- •are unable to understand the language in which the approved informed consent is written
- •have no pain measured on the Visual Analogue scale
- •are unable to walk, wheel chair bound or confined to bed
- •are deemed by the investigator to be unreliable to wear the actigraphy, to complete the sleep log, to use the provided mattress covers at the proper time, to come to the scheduled visits or to answer questions regarding the subject's condition or medication use
- •lack a mobile arm to which to attach an actigraphy.
- •are currently participate or participated in another clinical study within the past 30 days
- •demonstrate an unwillingness to comply with the maximum limit of two alcoholic drinks per day and only 1 alcoholic drink after 6:00 P.M. for the duration of the protocol
- •use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle
- •have any unstable medical condition as determined by the investigator, or any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol
结局指标
主要结局
Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).
时间窗: 14 days
The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention). The daily scores range from 1 (very much improved) to 7 (very much worse).
次要结局
- Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.(Assessed daily for 14 days per intervention.)
- Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.(Assessed daily for 14 days per intervention.)
- Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.(Assessed daily for 14 days per intervention.)
- Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.(Assessed daily for 14 days per intervention.)
- Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.(Assessed daily for 14 days per intervention.)
研究者
Annabel Kim Wang
Associate Clinical Professor
University of California, Irvine