优化护士的睡眠健康 (OSHIN)
2024年2月8日 更新者：Jessee Dietch、Oregon State University
试点针对轮班工人失眠的认知行为疗法（CBTI-Shift）
拟议研究的目的是试点测试两种行为睡眠干预策略，以改善夜班护士的失眠状况。
研究概览
详细说明
符合所有研究标准的患有失眠症的夜班护士将接受两种失眠疗法中的一种。
失眠的具体治疗方法将由机会决定（就像抛硬币一样），接受失眠认知行为疗法或失眠多成分放松疗法的机会均等，两者均针对轮班工人进行了修改。
这两种疗法都将由接受过行为睡眠医学培训的干预专家通过远程医疗进行。
研究类型
介入性
注册 (估计的)
60
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。
学习联系方式
- 姓名：Jessica R Dietch, PhD
- 电话号码：541-737-1358
- 邮箱：jessee.dietch@oregonstate.edu
研究联系人备份
- 姓名：Lucy Kozii, MD, MPH
- 邮箱：koziil@oregonstate.edu
学习地点
-
-
Oregon
-
Corvallis、Oregon、美国、97331
- 招聘中
- Oregon State University
-
接触：
- Jessee Dietch, PhD
- 电话号码：541-737-1358
- 邮箱：jessee.dietch@oregonstate.edu
-
首席研究员：
- Jessee Dietch, PhD
-
-
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
- 成人
- 年长者
接受健康志愿者
是的
描述
纳入标准：
- 俄勒冈州现任轮班护士
- 预计在学习期间继续轮班工作安排
- 符合失眠症的标准
- 失眠症状加重
- 每天通过智能手机、平板电脑或电脑访问互联网；和
- 能用英语读写
排除标准：
- 健康状况不受控制的人
- 存在安全风险或参与研究可能无效或导致安全风险增加的情况
- 目前治疗失眠的一些方法
- 固定的白班、晚班或轮班时间表
- 有癫痫发作或躁狂发作史；或者
- 研究期间当前/预期怀孕
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：治疗
- 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 |
|---|---|
|
其他：CBTI
失眠的认知行为疗法
|
干预措施包括睡眠教育以及改善睡眠的行为和认知策略
其他名称：
|
|
其他：磁共振成像
多成分放松疗法治疗失眠
|
干预措施包括睡眠教育以及改善睡眠的行为和放松策略
其他名称：
|
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 |
|---|---|---|
|
失眠严重程度指数的变化
大体时间：基线和治疗后评估（大约 10 周时发生）
|
经过验证的调查问卷；总分范围在 0 到 28 之间，数字越高代表失眠严重程度越高
|
基线和治疗后评估（大约 10 周时发生）
|
|
保留率
大体时间：治疗后评估（大约 10 周时进行）
|
定义为[完成最低治疗剂量（至少 4 次）的参与者数量]/[治疗组中随机参与者的数量]
|
治疗后评估（大约 10 周时进行）
|
|
会议出席率
大体时间：治疗后评估（大约 10 周时进行）
|
对于已登记的参与者，出席率将计算为[出席的访问次数]/[总访问次数]
|
治疗后评估（大约 10 周时进行）
|
|
实施评估措施
大体时间：治疗后评估（大约 10 周时进行）
|
经过验证的调查问卷；总分范围在12到60之间，数字越高代表可行性、可接受性和适当性越高。
|
治疗后评估（大约 10 周时进行）
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
疲劳严重程度的变化
大体时间：基线和治疗后评估（大约 10 周时发生）
|
经过验证的调查问卷；总分范围在 9 到 63 之间，数字越高代表疲劳程度越高。
|
基线和治疗后评估（大约 10 周时发生）
|
|
PROMIS 睡眠相关障碍的变化 8 项
大体时间：基线和治疗后评估（大约 10 周时发生）
|
经过验证的调查问卷；总分范围在 8-40 之间，数字越高表明与睡眠相关的觉醒时间障碍越严重
|
基线和治疗后评估（大约 10 周时发生）
|
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：Jessica Dietch, PhD、Oregon State University
出版物和有用的链接
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- Huang LB, Tsai MC, Chen CY, Hsu SC. The effectiveness of light/dark exposure to treat insomnia in female nurses undertaking shift work during the evening/night shift. J Clin Sleep Med. 2013 Jul 15;9(7):641-6. doi: 10.5664/jcsm.2824.
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- Hallbeck MS, Lowndes BR, Bingener J, Abdelrahman AM, Yu D, Bartley A, Park AE. The impact of intraoperative microbreaks with exercises on surgeons: A multi-center cohort study. Appl Ergon. 2017 Apr;60:334-341. doi: 10.1016/j.apergo.2016.12.006. Epub 2016 Dec 29.
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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 (实际的)
2023年12月8日
初级完成 (估计的)
2025年1月14日
研究完成 (估计的)
2025年8月11日
研究注册日期
首次提交
2023年7月12日
首先提交符合 QC 标准的
2023年7月19日
首次发布 (实际的)
2023年7月28日
研究记录更新
最后更新发布 (实际的)
2024年2月12日
上次提交的符合 QC 标准的更新
2024年2月8日
最后验证
2024年2月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB-2021-1200
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
去识别化的数据可以上传到数据存储库，以便可以发布。
IPD 共享时间框架
数据将在与主要目标相关的结果发布后 2 年内提供，并且将提供至少 2 年。
IPD 共享访问标准
数据只会与有明确、严格的分析计划并与主要研究者签署数据使用协议的研究者共享。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
CBTI的临床试验
-
The University of Hong KongChinese University of Hong Kong; University of Oxford招聘中
-
University of MichiganAmerican Gastroenterological Association完全的
-
Washington State UniversityNational Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS)完全的
-
Diakonhjemmet Hospital主动，不招人