Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders (DoA-CLAS)

August 4, 2026 updated by: Anna Castelnovo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Canton Ticino
      • Lugano, Canton Ticino, Switzerland, 6962
        • Ospedale Italiano di Lugano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
Device: Closed-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.
Experimental: 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.
Device: Closed-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation 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.
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)
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.
Assessed during the stimulation-night overnight recording, up to 6 weeks.
Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic Stimulation
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)
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
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.
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
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.
Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of DoA Episodes With Reported Conscious Experience: Spontaneous vs. Stimulation-Elicited Episodes
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).
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
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).
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)
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.
Assessed during the closed-loop pilot phase (Phase 3b), within a subset of participants, up to 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anna Castelnovo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bologna
University of Wisconsin, Madison
Swiss National Science Foundation
University of Applied Sciences and Arts of Southern Switzerland
University of the Italian Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Castelnovo, Neurocenter of Southern Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMBIZIONE-DoA-CLAS-2026
  • PZ00-3_233285 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF), Ambizione Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

Beginning approximately 12 months after publication of the primary results, with no specified end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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