Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders (DoA-CLAS)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Anna Castelnovo, MD, PhD
- 電話番号：0041 918116117
- メール：anna.castelnovo@eoc.ch
研究連絡先のバックアップ
- 名前：Mauro Manconi, MD, PhD
- 電話番号：0041918116869
- メール：mauro.manconi@eoc.ch
研究場所
-
-
Canton Ticino
-
Lugano、Canton Ticino、スイス、6962
- Ospedale Italiano di Lugano
-
コンタクト：
- Anna Castelnovo, MD, PhD
- 電話番号：+41 91 811 6117
- メール：anna.castelnovo@eoc.ch
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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.
|
|
|
実験的：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.
|
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.
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation Night
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation Night
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of DoA Episodes With Reported Conscious Experience: Spontaneous vs. Stimulation-Elicited Episodes
時間枠：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
時間枠：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)
時間枠：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.
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Anna Castelnovo、Neurocenter of Southern Switzerland
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AMBIZIONE-DoA-CLAS-2026
- PZ00-3_233285 (その他の助成金/資金番号：Swiss National Science Foundation (SNSF), Ambizione Grant)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。