Sleep Enhancing Tools: Pilot Study
Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- UMichigan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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.
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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.
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安慰剂比较:Inert Control
Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
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Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
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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
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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.
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Baseline to day 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
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Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay
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number hospital days between administration of tool and hospital discharge
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effect of sleep enhancing tools on medication use
大体时间:baseline to day 3
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Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication
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baseline to day 3
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Effect of sleep enhancing tools on participation in Occupational therapy
大体时间:baseline to day 3
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Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study
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baseline to day 3
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合作者和调查者
调查人员
- 首席研究员:Peter Farrehi, MD、University of Michigan
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- HUM00075628
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