Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-60
SponsorAnna Castelnovo
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)
DeviceBrief, 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.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: DoA - No-Stimulation Night (Baseline)No intervention 0 interventions
Group B: DoA - Acoustic Stimulation NightExperimental treatment 1 intervention
Group C: Healthy Control - Single Stimulation NightExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation Night
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 weeksSecondary outcomes
1
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation Night
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 two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks.2
Proportion of Slow-Wave Sleep Epochs With Successful Stimulation Trigger (Percentage)
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 during the stimulation-night overnight recording, up to 6 weeks.3
Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic Stimulation
Participant-rated discomfort attributable to acoustic stimulation, using a 0-10 visual analogue scale (0 = no discomfort, 10 = worst imaginable discomfort)
Time frame
Assessed the morning following the stimulation night, up to 6 weeks.4
Arousal Index (EEG Arousals per Hour of Sleep): Stimulation Night vs. No-Stimulation Night
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.Other outcomes
1
Proportion of DoA Episodes With Reported Conscious Experience: Spontaneous vs. Stimulation-Elicited Episodes
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
Assessed immediately after each DoA episode during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.2
Source-Level EEG Spectral Power (Delta 0.5-4 Hz and Beta 18-30 Hz Bands): Spontaneous vs. Stimulation-Elicited DoA Episodes
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
Derived from continuous high-density EEG recorded during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.3
Odds Ratio of DoA Episode Occurrence During EEG-Defined Fragility vs. Refractory Stimulation Windows (Closed-Loop Feasibility)
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.
Time frame
Assessed during the closed-loop pilot phase (Phase 3b), within a subset of participants, up to 6 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anna Castelnovo
Lead sponsor
Neurocenter of Southern Switzerland
Sponsor institution
Swiss National Science Foundation
Collaborator
University of Bologna
Collaborator
University of Wisconsin, Madison
Collaborator
University of the Italian Switzerland
Collaborator
University of Applied Sciences and Arts of Southern Switzerland
Collaborator
Source ClinicalTrials.gov
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