UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062320 |
|---|---|
| Receipt number | R000071319 |
| Scientific Title | Association of Alzheimer's Disease Biomarkers with ICU Delirium and Sleep Disturbances |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/07/23 17:48:31 |
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Basic information
Public title
Association of Intracerebral Neurotoxic Substances with ICU Delirium and Sleep Disturbances in Critically Ill Patients.
Acronym
Intracerebral Neurotoxic Substances and ICU Delirium and Sleep Disturbances.
Scientific Title
Association of Alzheimer's Disease Biomarkers with ICU Delirium and Sleep Disturbances
Scientific Title:Acronym
Alzheimer's Disease Biomarkers with ICU Delirium and Sleep Disturbances
Region
| Japan |
Condition
Condition
critically ill patients in the ICU
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We designed a clinical study to investigate the relationship between the development of ICU-acquired delirium (ICU-AD), a condition that worsens the prognosis of critically ill patients, and the neurotoxic brain proteins amyloid beta (AB) and Tau. ICU-AD is associated with prolonged ICU stays, increased medical costs, higher in-hospital mortality rates, and cognitive impairment following ICU discharge. AB and Tau are metabolic waste products synthesized in the brain that are normally cleared during sleep. However, their accumulation exerts neurotoxic effects and contributes to the development of dementia and Alzheimer's disease. Recent studies have shown that AB accumulates in the brain even after short-term sleep disruption and can trigger perioperative delirium. Given that over 90% of ICU patients experience sleep disturbances, such disturbances are hypothesized to be a risk factor for ICU-AD; however, no research has yet examined the links between delirium onset and AB/Tau levels, or between sleep dynamics and AB/Tau concentrations in this patient population.
The objective of this study is to evaluate, using objective sleep data, whether sleep disturbances in ICU patients induce the accumulation of AB and Tau and contribute to the onset of delirium.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Association between the incidence of ICU-AD and serum AB/Tau concentrations
2. Association between sleep dynamics in the ICU and serum AB/Tau concentrations
Key secondary outcomes
Associations of sleep dynamics and serum AB/Tau concentrations in the ICU with post-discharge ADL independence (Barthel Index), cognitive function (MMSE), mental function (HADS), and physical function (J-CHS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years or older receiving treatment in the ICU who are capable of communication and are expected to have an ICU stay exceeding 72 hours.
Key exclusion criteria
Patients with a high probability of death within 72 hours of ICU admission
Patients with intracranial disorders (e.g., cerebral infarction, cerebral hemorrhage, head trauma, post-brain tumor resection)
Pediatric patients under 18 years of age
Pregnant or postpartum women
Patients with a history of epilepsy or status epilepticus
Patients with severe dementia
Patients with sleep disorders or sleep apnea
Patients with a history of delirium
Patients in a persistent coma since admission, making sleep assessment impossible
Patients for whom simplified polysomnography cannot be performed (e.g., due to forehead wounds or the attachment of other monitoring devices)
Patients resuscitated after cardiopulmonary arrest
Patients with severe anemia (Hb <7.0 g/dL) or hemorrhagic shock
Other patients deemed unsuitable by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Oto |
Organization
Tokushima University Graduate School of Biochemical Sciences
Division name
Emergency and Critical Care Medicine
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima-city, Tokushima, Japan
TEL
0886339347
joto@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Oto |
Organization
Tokushima University Graduate School of Biochemical Sciences
Division name
Emergency and Critical Care Medicine
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima-city, Tokushima, Japan
TEL
0886339347
Homepage URL
joto@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical and Translational Scinece
Address
2-50-1 Kuramoto-cho, Tokushima-city, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071319
