Ospedale Italiano di Lugano
Lugano, Canton Ticino, 6962, Switzerland
NCT Number: NCT07754838
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.
Trial opening soon.
Get Notified6 year–60 year
All sexes
Interventional
Not applicable
Lugano, Canton Ticino, 6962, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants with Disorders of Arousal (DoA):
For healthy volunteers:
Exclusion criteria
(all participants):
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Anna Castelnovo, MD, PhD
CONTACT
Mauro Manconi, MD, PhD
CONTACT
Anna Castelnovo
Other
Closed-Loop and Open-Loop Acoustic Stimulation During Sleep to Investigate and Modulate Disorders of Arousal in Children and Adults
Acronym: DoA-CLAS
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