[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620301":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":47,"responsibleParty":68,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":41,"maxAge":41,"enrollmentInfo":81,"targetDuration":41,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Verum arm","EXPERIMENTAL","Nightly enhancement of slow waves through Phase Targeted Auditory Stimulation (PTAS) over 18 months.",[13],"Device: Tosoo Axora",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham arm","SHAM_COMPARATOR","Nightly application of tones that will be applied in a non-PTAS manner, resulting in no enhancement of slow waves over 18 months.",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Tosoo Axora","Phase Targeted Auditory Stimulation (PTAS) will be applied through integrated headphones with a portable EEG device when non-rapid-eye-movement (NREM) sleep is detected during the night.",[9],[26],"PTAS Intervention (Verum)",{"type":21,"name":22,"description":28,"armGroupLabels":29,"otherNames":30},"Auditory stimuli will be delivered during the night through integrated headphones with a portable EEG device in a non-PTAS manner.",[15],[31],"PTAS Intervention (Sham)",[33],{"name":34,"affiliation":5,"role":35},"Andreas Luft, Prof. Dr. med.","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Jana Bünzli, MSc","CONTACT","+41 44 255 10 43",null,"jana.buenzli@usz.ch",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Marta Menéndez, Dr. phil.","+41 43 253 69 54","marta.menendezgranda@usz.ch",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospital Zurich, Neurology Department","RECRUITING","Zurich","Canton of Zurich","8091","Switzerland","CH",{"type":57,"coordinates":58},"Point",[59,60],8.55,47.36667,{"lat":60,"lon":59},[63,67],{"name":64,"role":39,"phone":65,"phoneExt":41,"email":66},"Angelina Maric, Dr. phil.","+41 255 86 15","angelina.maric@usz.ch",{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":69,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[71],{"name":72,"class":6},"University Hospital, Zürich","100620301","role-of-slow-waves-in-the-progression-of-neurodegeneration-in-isolated-rem-sleep-behavior-disorder-100620301",false,"NCT07355842","Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder","SloW-iRBD","Inclusion Criteria:\n\n* Signed informed consent\n* Diagnosis of polysomnography-confirmed isolated REM Sleep Behavior Disorder (iRBD) based on international criteria (ICSD-3), combined with EITHER\n* UPDRS III without action tremor ≥ 4 AND abnormal olfaction, OR\n* diagnosis of PD along international criteria for less than 2 years\n\nFurther inclusion criteria are:\n\n* no dopaminergic treatment and no foreseen start of such treatment during duration of the study\n* ability to apply the intervention, alone or with help of a co-habitant, stable living situation\n* sufficient language skills in German, French or Italian\n* negative pregnancy test for women of child-bearing potential\n\nExclusion Criteria:\n\n* Suspected or known non-compliance to other therapies\n* current or recent participation in another clinical trial\n* extended absences\n* hearing impairment that prevents hearing the tones for auditory stimulation\n* non-responder to auditory stimulation during screening\n* clinically significant concomitant disease or unstable condition\n* Apnea-Hypopnea-Index (AHI) \\> 15\u002Fh or under Continuous Positive Airway Pressure (CPAP) treatment\n* Restless Legs Syndrome\n* meeting criteria for diagnosis of atypical Parkinson syndrome\n* diagnosis of Dementia or Montreal Cognitive Assessment (MoCA) \\\u003C 24\n* severe Depression or other psychiatric disorder\n* regular use of benzodiazepines and other central nervous system depressant substances\n* current or recent history within the last year of substance abuse disorders or chronic alcohol consumption\n* recent or planned major surgery\n* history of allergies and hypersensitivity relevant for electrode application or medication allergies\n* additional exclusion criteria for PET imaging\n* any criterion that may pose the participant at risk\n* breastfeeding, intention to become pregnant, or unwillingness to use medically reliable contraception for women of child-bearing potential","ALL",{"count":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study tests whether enhancing deep sleep with gentle sounds at night can slow progression in people with iRBD or early Parkinson's disease. Participants wear a sensor headband and headphones for 18 months. Four assessments including mobility, memory, imaging (PET\u002FMRI), lumbar puncture, and blood tests are assessed.",[89,90],"Parkinson Disease","REM Sleep Behavior Disorder (iRBD)",[92,93,94,95,96,97,98],"Parkinson","Parkinson disease","Sleep","Neurodegeneration","Auditory stimulation","iRBD","REM sleep behavior disorder","2026-02-16",{"date":101,"type":102},"2026-02-17","ACTUAL",{"date":104,"type":102},"2026-01-15",{"date":106,"type":83},"2029-06-30",{"name":5,"class":6},1]