[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05234866":3,"trial-entities:NCT05234866":92,"trial-summary:NCT05234866":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":26,"secondary_outcomes":46,"sex":52,"minimum_age":53,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":54,"std_ages":64,"locations":67,"central_contacts":79,"overall_officials":88,"references":90,"see_also_links":91},"NCT05234866","20-01854","Paradoxical Lucidity in Severe End-Stage Dementia","RECRUITING","2027-05-31","2026-07","2026-07-10","2022-06-02","NYU Langone Health","OTHER",false,"Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transient PL events occurring in patients predominantly in late-stage dementia and typically lasting anywhere from a few minutes to several hours, little is known about PL. The study team proposes to develop and conduct a mixed methods prospective study of PL during end stage advanced dementia, creating a definition and measurement scale for PL in advanced dementia, and identifying the potential electro cortical biomarkers of PL in advanced dementia. This study will be divided in two phases: Phase I and Phase II. During Phase I, the study team will collect sufficient and necessary data through an online survey and focus groups as well as assess the safety and feasibility of using symptom diaries (also known as daily trackers or journals) and real-time video EEG monitoring (vEEG). After preliminary review of the study procedures, the PI will decide whether to move onto the Phase II. The second phase will aim to expand the study population and refine study methods as well as create a definition and measurement scale for PL in advances dementia.",null,[18],"Dementia",[],"OBSERVATIONAL",[],{"count":23,"type":24},520,"ESTIMATED",[],[27,30,32,34,36,38,40,42,44],{"measure":28,"timeFrame":29},"Phase I and II - Number of self-reports of patient distress\u002Fdiscomfort in relation to symptom diary use and recording of potential episodes of paradoxical lucidity (PL) using mobile devices","up to Day 7",{"measure":31,"timeFrame":29},"Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.",{"measure":33,"timeFrame":29},"Phase I - Number of families who express interest in the study and contact the research team",{"measure":35,"timeFrame":29},"Phase I - Number of successful informed consents obtained from family members\u002Flegally authorized health care proxies",{"measure":37,"timeFrame":29},"Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy \u003C\u002F= 7 days",{"measure":39,"timeFrame":29},"Phase I - Number of diary reports completed and returned to research staff",{"measure":41,"timeFrame":29},"Phase I - Time taken to establish video EEG monitoring in homes or nursing homes",{"measure":43,"timeFrame":29},"Phase I - Total number of instances in which video EEG monitoring was successfully initiated",{"measure":45,"timeFrame":29},"Phase I - Average number of days for which video EEG monitoring was completed",[47,50],{"measure":48,"timeFrame":49},"Phase II - Change in average number of changes in EEG rhythm","Baseline, up to Day 7",{"measure":51,"timeFrame":49},"Phase II - Average number of changes in EEG rhythm during PL","ALL","18 Years",{"inclusion":55,"exclusion":61,"raw_text":63},[56,57,58,59,60],"Age \\> 18 years","Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%","Accepted for hospice care based on the Medicare eligibility guidelines","No longer being provided with nutrition or fluids","Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period",[62],"Cognitive or functional impairment due to a diagnosis other than dementia","Inclusion Criteria:\n\n* Age \\> 18 years\n* Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%\n* Accepted for hospice care based on the Medicare eligibility guidelines\n* No longer being provided with nutrition or fluids\n* Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period\n\nExclusion Criteria:\n\n* Cognitive or functional impairment due to a diagnosis other than dementia\n* Dementia with a GDS score \\\u003C7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":12,"status":7,"city":69,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":76},"New York","10016","United States",[73],{"name":74,"role":75},"Sam Parnia, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},40.71427,-74.00597,[80,84],{"name":74,"role":81,"phone":82,"email":83},"CONTACT","(646)-501-6923","Sam.Parnia@nyulangone.org",{"name":85,"role":81,"phone":86,"email":87},"Natalia Leontovich","917-227-0932","pl@nyulangone.org",[89],{"name":74,"affiliation":12,"role":75},[],[],{"nct_id":4,"conditions":93,"biomarkers":94},[18],[],{"nct_id":4,"found":96,"summary":97,"prompt_version":107},true,{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an observational study, meaning researchers will watch and record information without giving any specific treatments. It plans to enroll 520 participants and is divided into two phases.","completed","Observational Study of Paradoxical Lucidity in Severe End-Stage Dementia","This study is looking into \"paradoxical lucidity\" (PL), which are unexpected moments of clarity that some people with severe dementia experience. While cognitive decline in dementia is usually seen as permanent, these brief episodes suggest there might be other things happening in the brain. Currently, we don't know much about PL beyond personal stories. This study aims to define what PL is, create a way to measure it, and identify any brain signals (electrocortical biomarkers) linked to these moments in people with advanced dementia. You could be eligible if you are over 18, have severe dementia (Global Deterioration Scale score of 7 or Palliative Performance Scale score less than 30%), are in hospice care, and are no longer receiving nutrition or fluids.","The study will track self-reports of patient distress\u002Fdiscomfort and potential PL episodes for up to 7 days. Informant distress related to video EEG devices will also be measured for up to 7 days.",122,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]