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Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders (DoA-CLAS)

2026年8月4日 更新者：Anna Castelnovo

Closed-Loop and Open-Loop Acoustic Stimulation During Sleep to Investigate and Modulate Disorders of Arousal in Children and Adults

Disorders of Arousal (DoA)-such as sleepwalking, sleep terrors, and confusional arousals-are common sleep problems that happen during deep, non-dreaming sleep. Researchers do not fully understand what triggers these episodes or how to influence them.

This study tests whether playing soft sounds during sleep can help researchers learn more about, and possibly induce or modulate, these episodes under safe, supervised conditions. Participants with DoA will spend two nights in the sleep laboratory, with painless sensors placed on the scalp and body (similar to a regular sleep study). On one night, no sound is played. On the other night, soft sounds are played during deep sleep. The order of the two nights is decided randomly for each participant.

A small group of healthy volunteers without DoA will also take part, undergoing a single night with sound stimulation, to help researchers understand whether the sounds affect everyone the same way or specifically trigger episodes in people with DoA.

A subgroup of participants with DoA will also take part in a later, exploratory step in which the sound is triggered automatically, in real time, based on brain activity patterns.

The sounds used are very quiet, similar in volume to normal conversation, and stimulation is stopped right away if a participant shows any discomfort. The goal of this research is to better understand what triggers Disorders of Arousal, and to test whether sound-based stimulation could one day help study or manage this condition.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Disorders of Arousal (DoA)-including sleepwalking, sleep terrors, and confusional arousals-are NREM parasomnias whose underlying neurophysiological triggers remain poorly understood. A growing body of evidence suggests that DoA episodes do not emerge randomly from sleep but arise from identifiable pre-episode EEG states characterized by increased slow-wave activity and reduced cortical activation, consistent with a transient state of arousal instability. Closed-loop acoustic stimulation (CLAS) is an established, non-invasive method for probing and modulating NREM sleep physiology, but has not previously been applied in the specific context of NREM parasomnias.

This study investigates whether controlled acoustic stimulation, initially delivered with randomized timing and subsequently in a real-time, EEG-triggered closed-loop fashion, can reliably elicit or modulate DoA episodes under supervised laboratory conditions. A small group of healthy volunteers undergoes a single stimulation night to estimate the specificity of stimulation-elicited motor responses, helping distinguish genuine DoA vulnerability from a non-specific arousal response to sound.

The within-subject, randomized-order design in DoA participants allows each to serve as their own control, isolating the effect of acoustic stimulation from other sources of night-to-night variability. The exploratory closed-loop sub-study tests the technical feasibility of triggering stimulation based on real-time EEG markers of vulnerability, representing a first step toward future predictive or modulation-based approaches for this condition.

This study is part of a broader research programme on the neurobiological characterization of Disorders of Arousal; related observational components (including neuroimaging, neuropsychological assessment, and home monitoring) are registered separately.

研究类型

介入性

注册 (估计的)

50

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

研究联系人备份

学习地点

  • 瑞士
    • Canton Ticino
      • Lugano、Canton Ticino、瑞士、6962
        • Ospedale Italiano di Lugano
        • 接触：

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

  • 孩子
  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

For participants with Disorders of Arousal (DoA):

  • Diagnosis of a Disorder of Arousal (sleepwalking, sleep terror, or confusional arousal) per ICSD-3 criteria, confirmed by video-polysomnography or by clinical diagnosis plus a positive Arousal Disorders Questionnaire (ADQ) and compatible history
  • Age 6-17 years (paediatric) or 18-60 years (adult) at enrollment
  • At least one documented episode in the 4 weeks (paediatric) or 6 months (adult) prior to enrollment
  • Ability to understand and complete study materials in Italian
  • Written informed consent (and age-appropriate assent for minors, per Swiss Human Research Act Art. 22-23)

For healthy volunteers:

  • No documented sleep disorder, confirmed by clinical interview, questionnaires, or prior instrumental examination
  • Age- and sex-matched to the paediatric DoA group
  • No clinically significant psychiatric or neurological history
  • Written informed consent and age-appropriate assent

Exclusion Criteria (all participants):

  • Epilepsy or other major neurological disorder
  • Comorbid REM sleep behavior disorder or other REM parasomnia
  • Current psychopharmacological or psychotropic medication (except melatonin ≤2 mg)
  • Neurodevelopmental disorder precluding protocol collaboration (paediatric participants)
  • Clinically relevant sleep-disordered breathing (Apnea-Hypopnea Index >5 events/hour)
  • Clinically significant hearing deficit
  • Significant sleep deprivation in the 48 hours prior to laboratory recording
  • Pregnancy (adult participants)
  • Inadequate EEG recording quality (>40% artifact channels or epochs) - applied at the session level

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：基础科学
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
无干预：DoA - No-Stimulation Night (Baseline)
Participants with DoA (N=55) undergo overnight high-density EEG and video-polysomnography with no acoustic stimulation. Within-subject baseline condition; order relative to Arm 2 is randomized per participant.
实验性的：DoA - Acoustic Stimulation Night
The same DoA participants (N=55) undergo overnight high-density EEG and video-polysomnography with low-intensity open-loop acoustic stimulation delivered during slow-wave sleep; order relative to Arm 1 is randomized per participant. A subset of 10 participants additionally undergoes a later, exploratory real-time closed-loop stimulation sub-phase.
设备：Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)
Brief, low-intensity auditory stimuli (pure tones or noise bursts, 50-70 dB SPL, approximately 1 second in duration) delivered via a standard speaker during confirmed slow-wave sleep (SWS). In the initial open-loop phase, stimuli are presented with randomized timing. In a later closed-loop sub-study, stimuli are triggered automatically in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows. Stimulation is immediately interrupted in the event of distress, full awakening, or any adverse reaction.
实验性的：Healthy Control - Single Stimulation Night
A separate group of healthy participants (N=5) undergoes a single overnight high-density EEG and video-polysomnography recording including open-loop acoustic stimulation during slow-wave sleep, to estimate the specificity of stimulation-elicited motor responses relative to the DoA group.
设备：Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)
Brief, low-intensity auditory stimuli (pure tones or noise bursts, 50-70 dB SPL, approximately 1 second in duration) delivered via a standard speaker during confirmed slow-wave sleep (SWS). In the initial open-loop phase, stimuli are presented with randomized timing. In a later closed-loop sub-study, stimuli are triggered automatically in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows. Stimulation is immediately interrupted in the event of distress, full awakening, or any adverse reaction.

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
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation Night
大体时间：Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks
Number of video-polysomnographically confirmed Disorders of Arousal (DoA) episodes (sleepwalking, sleep terror, or confusional arousal), compared within-subject between the stimulation night and the no-stimulation (baseline) night.
Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks

次要结果测量

结果测量
措施说明
大体时间
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation Night
大体时间：Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks.
Mean duration (seconds) of video-polysomnographically confirmed DoA episodes, compared within-subject between the stimulation night and the no-stimulation (baseline) night.
Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks.
Proportion of Slow-Wave Sleep Epochs With Successful Stimulation Trigger (Percentage)
大体时间：Assessed during the stimulation-night overnight recording, up to 6 weeks.
Percentage of detected slow-wave sleep epochs in which acoustic stimulation was successfully triggered within the predefined target window, during the stimulation night.
Assessed during the stimulation-night overnight recording, up to 6 weeks.
Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic Stimulation
大体时间：Assessed the morning following the stimulation night, up to 6 weeks.
Participant-rated discomfort attributable to acoustic stimulation, using a 0-10 visual analogue scale (0 = no discomfort, 10 = worst imaginable discomfort)
Assessed the morning following the stimulation night, up to 6 weeks.
Arousal Index (EEG Arousals per Hour of Sleep): Stimulation Night vs. No-Stimulation Night
大体时间：Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Arousal index (number of EEG-defined arousals per hour of total sleep time, scored per AASM criteria), compared between the stimulation night and the no-stimulation night.
Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Sleep Efficiency (Percentage): Stimulation Night vs. No-Stimulation Night
大体时间：Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Sleep efficiency (percentage of time in bed spent asleep), derived from polysomnographic sleep staging, compared between the stimulation night and the no-stimulation night.
Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.

其他结果措施

结果测量
措施说明
大体时间
Proportion of DoA Episodes With Reported Conscious Experience: Spontaneous vs. Stimulation-Elicited Episodes
大体时间：Assessed immediately after each DoA episode during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Percentage of DoA episodes associated with a reported conscious experience (recalled or unrecalled mental content, assessed via immediate post-episode interview), compared between spontaneous episodes (no-stimulation night) and stimulation-elicited episodes (stimulation night).
Assessed immediately after each DoA episode during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Source-Level EEG Spectral Power (Delta 0.5-4 Hz and Beta 18-30 Hz Bands): Spontaneous vs. Stimulation-Elicited DoA Episodes
大体时间：Derived from continuous high-density EEG recorded during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Power spectral density in the delta and beta bands, source-localized, compared between spontaneous DoA episodes (no-stimulation night) and stimulation-elicited DoA episodes (stimulation night).
Derived from continuous high-density EEG recorded during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Odds Ratio of DoA Episode Occurrence During EEG-Defined Fragility vs. Refractory Stimulation Windows (Closed-Loop Feasibility)
大体时间：Assessed during the closed-loop pilot phase (Phase 3b), within a subset of participants, up to 6 weeks.
Odds ratio of DoA episode occurrence when stimulation is delivered during EEG-defined fragility windows versus randomly selected refractory windows, in the exploratory closed-loop pilot sub-study.
Assessed during the closed-loop pilot phase (Phase 3b), within a subset of participants, up to 6 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。

赞助

Anna Castelnovo

合作者

University of Bologna
University of Wisconsin, Madison
Swiss National Science Foundation
University of Applied Sciences and Arts of Southern Switzerland
University of the Italian Switzerland

调查人员

  • 首席研究员：Anna Castelnovo、Neurocenter of Southern Switzerland

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 (估计的)

2026年10月1日

初级完成 (估计的)

2030年7月30日

研究完成 (估计的)

2030年7月30日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年8月4日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AMBIZIONE-DoA-CLAS-2026
  • PZ00-3_233285 (其他赠款/资助编号：Swiss National Science Foundation (SNSF), Ambizione Grant)

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

De-identified individual participant data underlying the primary and secondary outcome measures (high-density EEG recordings, episode classification, and questionnaire-derived measures) will be made available following publication of the primary results, in accordance with the SNSF Open Research Data policy and FAIR Data Principles ("as open as possible, as closed as necessary").

Derived and anonymized EEG datasets and analysis code will be deposited in FAIR-compliant, non-commercial repositories (e.g., OpenNeuro, Zenodo) with persistent identifiers, and released under a Creative Commons Attribution license (CC BY 4.0), unless stronger restrictions are required.

Raw high-density EEG with synchronized video cannot be made openly available, as full anonymization is not feasible; these data will be deposited only in repositories supporting controlled access (e.g., EBRAINS), with access granted upon reasoned request to a Data Access Committee, subject to a Data Use Agreement and complian

IPD 共享时间框架

Beginning approximately 12 months after publication of the primary results, with no specified end date.

IPD 共享访问标准

Access to controlled raw data (EEG with video) is granted upon reasoned request to a Data Access Committee, subject to a Data Use Agreement reviewed by the EOC Data Protection Officer. Anonymized derived datasets and code are openly available without restriction.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 分析代码

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.

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