发作性睡病噩梦研究
2026年6月24日 更新者：Jennifer Mundt, PhD、Northwestern University
发作性睡病相关噩梦的行为治疗
该临床试验的目的是测试两种针对发作性睡病成人噩梦的行为疗法。 它旨在回答的主要问题是：
- 意象排练疗法 (IRT) 对发作性睡病相关的噩梦有效吗？
- 在 IRT 中添加有针对性的梦想控制 (TDC) 是否会使其更有效？
参与者将被随机分配到两个治疗组之一，并被要求：
- 每天完成长达 13 周的睡眠症状记录。
- 参加 5-7 次治疗。
- 完成治疗前后的问卷调查。
- 前往伊利诺伊州埃文斯顿的研究实验室，在白天小睡期间完成睡眠研究。
研究概览
研究类型
介入性
注册 (实际的)
7
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
-
-
Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
-
-
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 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 发作性睡病的诊断
- 年满 18 岁
- 说英语
- 居住在美国并能够参加伊利诺伊州埃文斯顿的学习预约
- 接受发作性睡病的标准医疗
- 睡眠和精神药物至少稳定 3 个月
- 每周噩梦频率≥3次
- 噩梦障碍指数评分表明可能是噩梦障碍
- 能够并且愿意在实验室访问当天不服用促醒药物
排除标准：
- 可能改变脑电图的神经系统疾病史
- 目前从事心理治疗
- 以前对噩梦的行为治疗
- 会干扰参与治疗能力的医学、精神或认知状况
- 未经治疗的睡眠呼吸暂停 (AHI ≥ 5)
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：意象排练疗法（IRT）
随机分配到该组的参与者将接受 7 次 IRT。
|
通过视频会议进行减少噩梦的治疗
其他名称：
|
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实验性的：意象排练疗法和有针对性的梦境控制（IRT+TDC）
随机分配到该组的参与者将接受 7 次 IRT+TDC。
|
通过视频会议进行减少噩梦的治疗
其他名称：
通过视频会议和实验室会议进行减少噩梦的治疗。
实验室课程将涉及白天小睡期间的睡眠研究。
其他名称：
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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 |
|---|---|---|
|
Nightmare Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
Frequency of nightmares as measured by daily diary
|
Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
|
Disturbing Dream and Nightmare Severity Scale
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures nightmare severity.
Minimum = 0, maximum = 37.
Higher scores represent a worse severity of nightmares.
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Baseline and posttreatment (up to 13 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome).
Population mean (T-score) of 50 with a standard deviation of 10.
|
Baseline and posttreatment (up to 13 weeks)
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome).
Population mean (T-score) of 50 with a standard deviation of 10.
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Baseline and posttreatment (up to 13 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dream Enactment Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
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Frequency of dream enactment as measured by daily diary
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Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
|
Sleep Talking Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
Frequency of sleep talking as measured by daily diary
|
Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
|
Lucid Dreams Without Control Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
Frequency of lucid dreams without control as measured by daily diary
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Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
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Lucid Dreams With Control Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
Frequency of lucid dreams with control as measured by daily diary
|
Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
|
Sleep-related Hallucinations Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
Frequency of sleep-related hallucinations as measured by daily diary
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Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
|
Sleep Paralysis Frequency
大体时间：Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
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Frequency of sleep paralysis as measured by daily diary
|
Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome).
Population mean (T-score) of 50 with a standard deviation of 10.
|
Baseline and posttreatment (up to 13 weeks)
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome).
Population mean (T-score) of 50 with a standard deviation of 10.
|
Baseline and posttreatment (up to 13 weeks)
|
|
Nightmare Disorder Index
大体时间：Baseline and posttreatment (up to 13 weeks)
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Measures nightmare severity.
Minimum = 0, maximum = 20.
Higher scores represent a worse severity of nightmares.
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Baseline and posttreatment (up to 13 weeks)
|
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Epworth Sleepiness Scale
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures daytime sleepiness.
Minimum = 0, maximum = 24.
Higher scores represent worse daytime sleepiness.
|
Baseline and posttreatment (up to 13 weeks)
|
|
Hypersomnia Severity Index
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures the severity of hypersomnia symptoms.
Minimum = 0, maximum = 36.
Higher scores represent worse symptoms.
|
Baseline and posttreatment (up to 13 weeks)
|
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Functional Outcomes of Sleep Questionnaire-10
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures daytime functioning related to hypersomnia.
Minimum = 5, maximum = 20.
Higher scores represent better functioning.
|
Baseline and posttreatment (up to 13 weeks)
|
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Paris Arousal Disorders Severity Scale
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures the severity of non-REM parasomnia symptoms.
Minimum = 0, maximum = 50.
Higher scores represent worse symptoms.
|
Baseline and posttreatment (up to 13 weeks)
|
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Lucid Dream Skills Questionnaire (LUSK)
大体时间：Baseline and posttreatment (up to 13 weeks)
|
The Lucid Dream Skills Questionnaire (LUSK) measures the frequency of lucid dreaming.
The LUSK total score ranges from 0-4 (the mean of the item scores), with higher scores representing a higher frequency of lucid dreaming.
In general, a higher frequency of lucid dreaming is not inherently "better" or "worse."
For the purpose of this trial, one of the intervention components (Targeted Dream Control) attempted to increase lucid dreaming, so a higher score for this trial would indicate an improvement.
|
Baseline and posttreatment (up to 13 weeks)
|
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Dream Delusions Scale
大体时间：Baseline and posttreatment (up to 13 weeks)
|
Measures the severity of dream delusions.
Minimum = 0, maximum = 12.
Higher scores represent worse dream delusions.
|
Baseline and posttreatment (up to 13 weeks)
|
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：Jennifer Mundt, PhD、Northwestern University
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2月22日
初级完成 (实际的)
2024年4月30日
研究完成 (实际的)
2024年4月30日
研究注册日期
首次提交
2023年1月24日
首先提交符合 QC 标准的
2023年1月24日
首次发布 (实际的)
2023年2月2日
研究记录更新
最后更新发布 (实际的)
2026年6月30日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年4月1日
更多信息
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.