[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651021":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":60,"collaborators":63,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":12,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":108,"whyStopped":12,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Neurocenter of Southern Switzerland","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Device: Closed-Loop\u002FOpen-Loop Acoustic Stimulation (CLAS)",{"label":20,"type":15,"description":21,"interventionNames":22},"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.",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DEVICE","Closed-Loop\u002FOpen-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.",[14,20],[30],{"name":31,"affiliation":5,"role":32},"Anna Castelnovo","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":12,"email":38},"Anna Castelnovo, MD, PhD","CONTACT","0041 918116117","anna.castelnovo@eoc.ch",{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},"Mauro Manconi, MD, PhD","0041918116869","mauro.manconi@eoc.ch",[44],{"facility":45,"status":12,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Ospedale Italiano di Lugano","Lugano","Canton Ticino","6962","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],8.96004,46.01008,{"lat":55,"lon":54},[58],{"name":35,"role":36,"phone":59,"phoneExt":12,"email":38},"+41 91 811 6117",{"type":61,"investigatorFullName":31,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Senior Physician \u002F Research Group Leader",[64,66,68,70,72],{"name":65,"class":6},"Swiss National Science Foundation",{"name":67,"class":6},"University of Bologna",{"name":69,"class":6},"University of Wisconsin, Madison",{"name":71,"class":6},"University of the Italian Switzerland",{"name":73,"class":6},"University of Applied Sciences and Arts of Southern Switzerland","100651021","acoustic-stimulation-to-study-and-modulate-sleepwalking-and-related-arousal-disorders-100651021",false,"NCT07754838","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","DoA-CLAS","Inclusion Criteria:\n\nFor participants with Disorders of Arousal (DoA):\n\n* 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\n* Age 6-17 years (paediatric) or 18-60 years (adult) at enrollment\n* At least one documented episode in the 4 weeks (paediatric) or 6 months (adult) prior to enrollment\n* Ability to understand and complete study materials in Italian\n* Written informed consent (and age-appropriate assent for minors, per Swiss Human Research Act Art. 22-23)\n\nFor healthy volunteers:\n\n* No documented sleep disorder, confirmed by clinical interview, questionnaires, or prior instrumental examination\n* Age- and sex-matched to the paediatric DoA group\n* No clinically significant psychiatric or neurological history\n* Written informed consent and age-appropriate assent\n\nExclusion Criteria (all participants):\n\n* Epilepsy or other major neurological disorder\n* Comorbid REM sleep behavior disorder or other REM parasomnia\n* Current psychopharmacological or psychotropic medication (except melatonin ≤2 mg)\n* Neurodevelopmental disorder precluding protocol collaboration (paediatric participants)\n* Clinically relevant sleep-disordered breathing (Apnea-Hypopnea Index \\>5 events\u002Fhour)\n* Clinically significant hearing deficit\n* Significant sleep deprivation in the 48 hours prior to laboratory recording\n* Pregnancy (adult participants)\n* Inadequate EEG recording quality (\\>40% artifact channels or epochs) - applied at the session level",true,"ALL","6 Years","60 Years",{"count":87,"type":88},50,"ESTIMATED","INTERVENTIONAL",[91],"NA","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.\n\nThis 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.\n\nA 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.\n\nA 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.\n\nThe 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.",[94,95,96,97],"NREM Parasomnias","Sleepwalking","Sleep Terrors","Confusional Arousals",[99,100,101,102,103,104,105,106,107],"Disorders of arousal","Somnambulism","Parasomnia","Consciousness","Closed-loop acoustic stimulation","High-density EEG","Slow-wave sleep","Pediatric sleep disorders","Sleep medicine","NOT_YET_RECRUITING","2026-08-04",{"date":111,"type":112},"2026-08-10","ACTUAL",{"date":114,"type":88},"2026-10-01",{"date":116,"type":88},"2030-07-30",{"name":31,"class":6},1]