UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036947 |
|---|---|
| Receipt number | R000042026 |
| Scientific Title | Clinical Factors Associated with Delirium |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2025/12/08 09:28:00 |
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Basic information
Public title
Clinical Factors Associated with Delirium
Acronym
Clinical Factors Associated with Delirium
Scientific Title
Clinical Factors Associated with Delirium
Scientific Title:Acronym
Clinical Factors Associated with Delirium
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine clinical factors associated with delirium in postoperative older patients, including quantitative electroencephalogram (EEG) measured by using a unispectral EEG devise with a noise-filtering system.
Basic objectives2
Others
Basic objectives -Others
To examine clinical factors associated with delirium in postoperative older patients, including quantitative EEG measured by using a unispectral EEG devise with a noise-filtering system.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative EEG associated with delirium
Key secondary outcomes
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age of 60 years or older
2) Being capable of providing informed consent
3) Inpatients at Keio University Hospital
4) Patients who will undergo spinal surgery
Key exclusion criteria
1) Having disturbance of consciousness
2) Having epilepsy
3) Having cognitive impairment or impaired capacity for understanding the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo,160-8582, Japan.
TEL
03-5363-3971
hiroyuki.uchida.hu@gmail.com
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
TEL
03-5363-3971
Homepage URL
takahito3332001@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
pending
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee.
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
76
Results
Significant differences in normalized power spectra between delirium and non-delirium states were found at multiple EEG frequencies during both the counting task and resting with eyes closed. Logistic regression identified 7-8 Hz and 12-15 Hz during the counting task, and 7-8 Hz and 13-14 Hz during rest as significant predictors. These results indicate that specific EEG frequency bands may characterize delirium.
Results date posted
| 2025 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged 60 years or older scheduled to undergo spine surgery
Participant flow
Eligible hospitalized patients received both written and verbal explanations, and written informed consent was obtained.
Adverse events
none
Outcome measures
After providing informed consent, participants will undergo EEG recording using a portable single-channel system, the Mini-Mental State Examination (MMSE) for cognitive assessment, and an evaluation of sleepiness.
Measurements will be performed up to four times: once preoperatively during hospitalization and 1-3 times within the first week after surgery, with at least 24 hours between each assessment.
At each measurement point, the severity of delirium will be assessed using the Confusion Assessment Method (CAM).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will wear the EEG device and EEG will be recorded for 6 minutes. Participants will also have interview with a trained interviewer(s)/psychiatrist(s) and their clinical symptoms will be assessed using the Mini-Mental State Examination (MMSE), Glasgow Coma Scale (GCS), Confusion Assessment Method (CAM), and a self-rating scale. The assessment will be performed up to 4 times on different days. Participants' clinico-demographics will be extracted from their medical records.
Management information
Registered date
| 2019 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042026
