Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders

NCT07754838 | Not Yet Recruiting

• 2 other identifiers: AMBIZIONE-DoA-CLAS-2026PZ00-3_233285
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

NREM Parasomnias; Sleepwalking; Sleep Terrors; Confusional Arousals

Keywords

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

Outcome Measures

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.

  Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks

Secondary Outcomes (5)

• Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation 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)

  Assessed during the stimulation-night overnight recording, up to 6 weeks.

• Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic Stimulation

  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

  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

  Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.

Other Outcomes (3)

• Proportion of DoA Episodes With Reported Conscious Experience: Spontaneous vs. Stimulation-Elicited Episodes

  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

  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)

  Assessed during the closed-loop pilot phase (Phase 3b), within a subset of participants, up to 6 weeks.

Study Arms (3)

DoA - No-Stimulation Night (Baseline)

NO INTERVENTION

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.

DoA - Acoustic Stimulation Night

EXPERIMENTAL

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.

Device: Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)

Healthy Control - Single Stimulation Night

EXPERIMENTAL

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.

Device: Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)

Interventions

Closed-Loop/Open-Loop Acoustic Stimulation (CLAS) DEVICE

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.

DoA - Acoustic Stimulation Night; Healthy Control - Single Stimulation Night

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Castelnovo: lead
• 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

Study Sites (1)

Ospedale Italiano di Lugano

Lugano, Canton Ticino, 6962, Switzerland

Location

MeSH Terms

Conditions

Somnambulism; Night Terrors; Sleep Arousal Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Anna Castelnovo

  Neurocenter of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Castelnovo, MD, PhD

CONTACT

0041 918116117; anna.castelnovo@eoc.ch

Mauro Manconi, MD, PhD

CONTACT

0041918116869; mauro.manconi@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician / Research Group Leader

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Beginning approximately 12 months after publication of the primary results, with no specified end date.
• Access Criteria: 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.

Locations

CH (1)