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临床试验/NCT02068703
NCT02068703已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Effect of use of sleep tool devices on length of stay(number hospital days between administration of tool and hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Farrehi MD

Clinical Assistant Professor

University of Michigan

研究点 (2)

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