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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05234866




Registration number
NCT05234866
Ethics application status
Date submitted
31/01/2022
Date registered
10/02/2022

Titles & IDs
Public title
Paradoxical Lucidity in Severe End-Stage Dementia
Scientific title
Paradoxical Lucidity in Severe End-Stage Dementia
Secondary ID [1] 0 0
20-01854
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase I (Feasibility Study) -

Phase II (Prospective Study) -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I and II - Number of self-reports of patient distress/discomfort in relation to symptom diary use and recording of potential episodes of paradoxical lucidity (PL) using mobile devices
Timepoint [1] 0 0
up to Day 7
Primary outcome [2] 0 0
Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.
Timepoint [2] 0 0
up to Day 7
Primary outcome [3] 0 0
Phase I - Number of families who express interest in the study and contact the research team
Timepoint [3] 0 0
up to Day 7
Primary outcome [4] 0 0
Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies
Timepoint [4] 0 0
up to Day 7
Primary outcome [5] 0 0
Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days
Timepoint [5] 0 0
up to Day 7
Primary outcome [6] 0 0
Phase I - Number of diary reports completed and returned to research staff
Timepoint [6] 0 0
up to Day 7
Primary outcome [7] 0 0
Phase I - Time taken to establish video EEG monitoring in homes or nursing homes
Timepoint [7] 0 0
up to Day 7
Primary outcome [8] 0 0
Phase I - Total number of instances in which video EEG monitoring was successfully initiated
Timepoint [8] 0 0
up to Day 7
Primary outcome [9] 0 0
Phase I - Average number of days for which video EEG monitoring was completed
Timepoint [9] 0 0
up to Day 7
Secondary outcome [1] 0 0
Phase II - Change in average number of changes in EEG rhythm
Timepoint [1] 0 0
Baseline, up to Day 7
Secondary outcome [2] 0 0
Phase II - Average number of changes in EEG rhythm during PL
Timepoint [2] 0 0
Baseline, up to Day 7

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cognitive or functional impairment due to a diagnosis other than dementia
* Dementia with a GDS score <7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
NYU Langone Health
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Aging (NIA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Parnia, MD, PhD
Address 0 0
NYU Langone Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sam Parnia, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
(646)-501-6923
Fax 0 0
Email 0 0
Sam.Parnia@nyulangone.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Available to whom?
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a date access agreement.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05234866