[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596881":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":11,"overallStatus":90,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Erasme University Hospital","OTHER",[8,14,17,20,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy young, auditory stimulation, then sham","EXPERIMENTAL",null,[13],"Other: Closed-loop acoustic stimulation",{"label":15,"type":10,"description":11,"interventionNames":16},"Healthy young, sham, then auditory stimulation",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Healthy old, auditory stimulation, then sham",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Healthy old, sham then auditory stimulation",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Positive amyloid load group, auditory stimulation, then sham",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"Positive amyloid load group, sham, then auditory stimulation",[13],[30],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Closed-loop acoustic stimulation","At-home sleep will be monitored using an EEG headband. Non-awakening auditory stimuli will be delivered during non-rapid eye movement sleep (NREM), timed to the ascending phase of slow waves, using either active or control (sham) conditions.",[18,21,9,15,24,27],[35],{"name":36,"affiliation":37,"role":38},"Mélanie Strauss, MD, PhD","Université Libre de Bruxelles","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":11,"email":43},"CONTACT","+32 2 555 55 39","melanie.strauss@hubruxelles.be",{"name":45,"role":41,"phone":11,"phoneExt":11,"email":46},"Rebeca Sifuentes Ortega, PhD","rebeca.sifuentes.ortega@ulb.be",[48],{"facility":49,"status":11,"city":50,"state":11,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hôpital Universitaire de Bruxelles","Brussels","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],4.34878,50.85045,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":42,"phoneExt":11,"email":43},"Mélanie Strauss",{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[65],{"name":66,"class":6},"University of Amsterdam","100596881","sleep-stimulation-to-enhance-waste-clearance-in-the-brain-100596881",false,"NCT07051239","Sleep Stimulation to Enhance Waste Clearance in the Brain","Enhancing Waste Clearance Through Sleep Stimulation","For the positive amyloid load group:\n\n-Participants who meet the criteria of subjective cognitive decline or mild cognitive impairment (Clinical Dementia Rating \\\u003C 2; Mini-Mental State Examination ≥ 21) and brain amyloid-beta (Aβ) accumulation confirmed by CSF or amyloid-PET, the inclusion age range is 55-80 years.\n\nFor healthy groups:\n\n-Inclusion age range is 18-80 years.\n\nInclusion criteria:\n\n* Proficiency in the French language (close to native level) to complete the neuropsychological evaluation and cognitive tests.\n* MRI compatibility: absence of metallic materials in the body (implants, vascular clips, certain types of orthopedic material, etc.), a pacemaker or other types of stimulators, cochlear implants, or any other electronic devices.\n\nExclusion criteria:\n\n* Current or past psychiatric or neurological conditions (except for those directly associated with the patient group).\n* The presence of severe untreated sleep disorders.\n* The presence of irregular sleep-wake cycles (due to shiftwork or extreme chronotype).\n* The presence of moderate depression or high levels of anxiety.\n* Ongoing treatment with psychotropic medications (benzodiazepines, antidepressants).\n* Regular or excessive consumption of alcohol or caffeinated drinks.\n* Consumption of other psychoactive substances known to have an impact on the central nervous system.\n* Insufficient visual or auditory acuity to complete the assessments if uncorrected. Normal hearing is required for sound stimulation to be effective.\n* Claustrophobia that prevents undergoing brain imaging (MRI).\n* Pregnancy or currently breastfeeding",true,"ALL","18 Years","80 Years",{"count":79,"type":80},105,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study aims to examine whether multi-night closed-loop auditory stimulation (CLAS) during sleep can enhance waste clearance and memory consolidation in healthy adults and older adults with subjective cognitive decline or mild cognitive impairment who exhibit elevated brain amyloid levels identified through prior clinical screening. Specifically, the study investigates whether sleep stimulation increases the clearance of plasma biomarkers related to neurodegeneration, improves the brain's waste clearance system, and supports memory consolidation. Participants will undergo five nights each of CLAS and sham (no stimulation) interventions, with a washout period in between. They will also complete clinical assessments, including MRI scans, blood sample collection, and cognitive testing, and will keep track of subjective sleep quality, sleepiness, mood, and fatigue throughout the interventions.",[86,87,88,89],"Healthy","Subjective Cognitive Decline (SCD)","Mild Cognitive Impairment (MCI)","Alzheimer Disease (AD)","NOT_YET_RECRUITING","2025-07-03",{"date":93,"type":94},"2025-07-09","ACTUAL",{"date":96,"type":80},"2025-09",{"date":98,"type":80},"2028-09",{"name":5,"class":6},1]