UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058993 |
|---|---|
| Receipt number | R000067468 |
| Scientific Title | Preventive Strategies for Perioperative Neurocognitive Disorders with a Focus on Sleep Disturbances: A Prospective Observational Study |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/04 16:40:30 |
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Basic information
Public title
Preventive Strategies for Perioperative Neurocognitive Disorders with a Focus on Sleep Disturbances: A Prospective Observational Study
Acronym
The Sleep and Perioperative Neurocognitive Disorders Project: A Prospective Observational Study
Scientific Title
Preventive Strategies for Perioperative Neurocognitive Disorders with a Focus on Sleep Disturbances: A Prospective Observational Study
Scientific Title:Acronym
The SPND Project (Sleep and Perioperative Neurocognitive Disorders Project)
Region
| Japan |
Condition
Condition
Perioperative Neurocognitive Disorders (PND)
Classification by specialty
| Neurology | Psychiatry | Operative medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This project aims to prevent perioperative neurocognitive disorders (PND) by focusing on sleep disturbances, clarifying their heterogeneous pathophysiology using biological and digital biomarkers, and establishing patient-tailored perioperative anesthetic and sedation management strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PND onset and the dynamics of biological and digital biomarkers, together with RNA signaling pathways, associated with sleep and psychiatric disorders
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included:
1. Patients undergoing surgery under general anesthesia at Hamamatsu University Hospital who are admitted to the ICU.
2. Patients judged by the attending physician to be eligible for participation in this study.
3. Patients who have provided written informed consent for participation in this study.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study:
1. Patients from whom collection of residual blood samples is difficult, requiring additional blood sampling, and who either did not provide consent or withdrew consent.
2. Patients judged by the attending physician to be inappropriate for participation.
3. Patients who already present with cognitive impairment at the time of hospital admission or in the preoperative phase.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yagi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Chuo-ku, Handayama, Hamamatsu 431-3192, Japan
TEL
0534352767
yagi5922@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yagi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Chuo-ku, Handayama, Hamamatsu 431-3192, Japan
TEL
0534352767
Homepage URL
yagi5922@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Chuo-ku, Handayama, Hamamatsu 431-3192, Japan
Tel
0534352680
rinri@hama-med.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
| 2025 | Year | 09 | Month | 05 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067468
