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Sleep Enhancing Tools: Pilot Study

2016年6月27日 更新者:Peter Farrehi MD、University of Michigan

Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey

To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise machine) in hospitalized patients can positively affect subjective symptoms of sleep quality, fatigue and pain.

研究概览

详细说明

A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.

We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.

The primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).

PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.

Information on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.

Our study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used.

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • UMichigan

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Admitted to a private room in the hospital
  • Speak and read english
  • expected length of stay > 2 days

Exclusion Criteria:

  • Hearing aids
  • sleep apnea using positive airway pressure therapy
  • medically or behaviorally unstable

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Intervention
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools (face mask, ear plugs and white noise machine) to improve sleep.
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.
安慰剂比较:Inert Control
Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Aggregate change in sleep /pain / fatigue scores on Patient Reported Outcomes Measurement Information System (PROMIS) survey sampled in hospital from baseline to day 3 between study groups
大体时间:Baseline to day 3
Change from baseline in sleep / pain / fatigue scores on PROMIS survey in the hospital. Each score ranges from 1-5, 1 equals not at all; 5 equals Very much.
Baseline to day 3

次要结果测量

结果测量
措施说明
大体时间
Effect of use of sleep tool devices on length of stay
大体时间:number hospital days between administration of tool and hospital discharge
Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay
number hospital days between administration of tool and hospital discharge

其他结果措施

结果测量
措施说明
大体时间
Effect of sleep enhancing tools on medication use
大体时间:baseline to day 3
Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication
baseline to day 3
Effect of sleep enhancing tools on participation in Occupational therapy
大体时间:baseline to day 3
Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study
baseline to day 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Peter Farrehi, MD、University of Michigan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2014年2月19日

首先提交符合 QC 标准的

2014年2月19日

首次发布 (估计)

2014年2月21日

研究记录更新

最后更新发布 (估计)

2016年6月28日

上次提交的符合 QC 标准的更新

2016年6月27日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HUM00075628

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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