[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":70,"collaborators":72,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":33,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":33,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Bern","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PLAS first, sham second","EXPERIMENTAL","In this study arm, participants will undergo a 4-week intervention period with real phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which sham (soundless) PLAS will be administered.",[13,14],"Other: Phase-locked auditory stimulation (PLAS)","Other: Sham Phase-Locked Auditory Stimulation",{"label":16,"type":10,"description":17,"interventionNames":18},"Sham first, PLAS second","In this study arm, participants will undergo a 4-week intervention period with sham (soundless) phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which real PLAS will be administered.",[13,14],[20,29],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Phase-locked auditory stimulation (PLAS)","Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device.\n\nThe experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink noise) during the positive half-waves of slow waves in slow-wave sleep (SWS). These stimuli are delivered through integrated headphones in the SleepLoop device. The intervention is applied during work days for 4 weeks. The algorithm is only active during SWS and does not deliver stimuli when the participant is awake, or in lighter sleep stages (N1, N2) or REM sleep. The intensity and algorithm sensitivity are individually calibrated for each participant to optimize stimulation.",[9,16],[25,26,27,28],"Acoustic stimulation","Phase-targeted auditory stimulation (PTAS)","Auditory stimulation","Closed-loop acoustic stimulation",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Sham Phase-Locked Auditory Stimulation","Participants will undergo the same procedure as the real Phase-Locked Auditory Stimulation (PLAS) intervention. However, during the sham condition, the headphones are turned off, and no auditory stimulation is delivered.",[9,16],null,[35],{"name":36,"affiliation":37,"role":38},"Marc A Züst, PhD","University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":33,"email":43},"CONTACT","+41 (0)58 630 95 02","marc.a.zuest@unibe.ch",{"name":45,"role":41,"phone":46,"phoneExt":33,"email":47},"Korian Wicki, Master","+41 76 605 24 00","korian.wicki@unibe.ch",[49],{"facility":50,"status":51,"city":52,"state":33,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern","RECRUITING","Bern","3000 60","Switzerland","CH",{"type":57,"coordinates":58},"Point",[59,60],7.44744,46.94809,{"lat":60,"lon":59},[63,65,69],{"name":45,"role":41,"phone":64,"phoneExt":33,"email":47},"+ 41 (0)58 630 68 77",{"name":66,"role":41,"phone":67,"phoneExt":33,"email":68},"Marina Wunderlin, PhD","+41 (0)31 932 87 07","marina.wunderlin@unibe.ch",{"name":36,"role":38,"phone":33,"phoneExt":33,"email":33},{"type":71,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[73,75],{"name":74,"class":6},"University of Zurich",{"name":76,"class":6},"Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)","100567542","effects-of-real-vs-soundless-acoustic-stimulation-during-deep-sleep-on-brain-activity-memory-and-blood-biomarkers-in-older-adults-60-85-with-mild-memory-impairment-100567542",false,"NCT06669546","Effects of Real vs. Soundless Acoustic Stimulation During Deep Sleep on Brain Activity, Memory, and Blood Biomarkers in Older Adults (60-85) With Mild Memory Impairment","Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement","Inclusion Criteria:\n\n* Written informed consent\n* Age between 60 and 85 years\n* Cognitive impairment (subjective and\u002For MoCA between 23-26)\n* Native German speakers or comparably fluent\n* Normal or corrected-to-normal vision.\n* Intact hearing\n* A close cohabitant (partner\u002Fsibling) should be present to support participants in using study materials\u002Fdevices.\n\nExclusion Criteria:\n\n* Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013)\n* Restless leg syndrome assessed by questions concerning typical symptoms.\n* Sleep apnoea assessed by the Berlin Questionnaire (BQ; Netzer et al., 1999)\n* Severely irregular sleep patterns assessed by the RIS and the Pittsburgh sleep quality index (PSQI; Buysse et al., 1989)\n* Symptoms of depression (Geriatric Depression Scale (GDS; Yesavage et al., 1982) ≥ 5)\n* History of untreated severe neurological and psychiatric diseases\n* Alcohol or substance abuse\n* Use of medication acting on the central nervous system","ALL","60 Years","85 Years",{"count":88,"type":89},60,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia.\n\nThe investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting.\n\nIn this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging \"serious games.\" Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline.\n\nIf successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.",[95,96,97,98,99],"Cognitive Decline","Alzheimer Disease","Subjective Cognitive Decline (SCD)","Mild Cognitive Impairment (MCI)","Cognitive Impairment, Mild",[101,102,103,104,105,106,107,108,109,110,111,112,113,114],"Sleep","Dementia","Prevention","Phase-locked auditory stimulation","Blood-based biomarkers","Home","Longitudinal","Electroneurophysiology","EEG","Memory","Cognition","Serious games","Old age","Human","2026-04-02",{"date":117,"type":118},"2026-04-03","ACTUAL",{"date":120,"type":118},"2025-02-21",{"date":122,"type":89},"2028-12",{"name":5,"class":6},1]