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Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07754838
Acronym
DoA-CLAS
Enrollment
50
Registered
2026-08-10
Start date
2026-10-01
Completion date
2030-07-30
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Confusional Arousals, NREM Parasomnias, Sleep Terrors, Sleepwalking

Keywords

Disorders of arousal, Somnambulism, Parasomnia, Consciousness, Closed-loop acoustic stimulation, High-density EEG, Slow-wave sleep, Pediatric sleep disorders, Sleep medicine

Brief summary

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.

Detailed description

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.

Interventions

DEVICEClosed-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.

Sponsors

Anna Castelnovo
Lead SponsorOTHER
Swiss National Science Foundation
CollaboratorOTHER
University of Bologna
CollaboratorOTHER
University of Wisconsin, Madison
CollaboratorOTHER
University of the Italian Switzerland
CollaboratorOTHER
University of Applied Sciences and Arts of Southern Switzerland
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

This is a randomized crossover design. Each DoA participant undergoes two within-subject conditions on separate laboratory nights, at least 48 hours apart: a no-stimulation (baseline) night and a stimulation night (randomized low-intensity acoustic stimulation during slow-wave sleep). The order in which each participant receives the two nights is randomized. A subset of participants additionally takes part in a later, exploratory closed-loop sub-study in which acoustic stimuli are triggered in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows.

Eligibility

Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation NightAssessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeksNumber 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.

Secondary

MeasureTime frameDescription
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation NightAssessed 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.
Proportion of Slow-Wave Sleep Epochs With Successful Stimulation Trigger (Percentage)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.
Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic StimulationAssessed 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)
Arousal Index (EEG Arousals per Hour of Sleep): Stimulation Night vs. No-Stimulation NightAssessed 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.
Sleep Efficiency (Percentage): Stimulation Night vs. No-Stimulation NightAssessed 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.

Countries

Switzerland

Contacts

CONTACTAnna Castelnovo, MD, PhD
anna.castelnovo@eoc.ch0041 918116117
CONTACTMauro Manconi, MD, PhD
mauro.manconi@eoc.ch0041918116869
PRINCIPAL_INVESTIGATORAnna Castelnovo

Neurocenter of Southern Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026