UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050575 |
|---|---|
| Receipt number | R000057606 |
| Scientific Title | Effect of sleep state change due to surgery |
| Date of disclosure of the study information | 2023/03/13 |
| Last modified on | 2023/03/13 19:31:12 |
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Basic information
Public title
Survey of perioperative sleep conditions
Acronym
change of perioperative sleep conditions
Scientific Title
Effect of sleep state change due to surgery
Scientific Title:Acronym
Effect of perioperative sleep state change due to operative stress
Region
| Japan |
Condition
Condition
healthy patient
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring the perioperative sleep state of patients who are scheduled to undergo surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
depth of sleep
time of sleeping
Heart rate change during sleep
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy patients
Key exclusion criteria
Patients diagnosed with mental illness
Patients who need assistance in daily life
Patients who are judged by researchers to be inappropriate as research subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | yokoyama |
| Middle name | |
| Last name | takeshi |
Organization
KYUSHU UNIVERSITY
Division name
Department of Dental Anesthesiology
Zip code
8140003
Address
FUKUOK-SHI, HIGASHI-K, MAIDASHI 3-1-1
TEL
092-641-1151
tsukamoto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | MASANORI |
| Middle name | |
| Last name | TSUKAMOTO |
Organization
Kyushu University Hospital
Division name
Department of Dental Anesthesiology
Zip code
8140003
Address
FUKUOKA-SHI, HIGASHI-KU MAIDASHI 3-1-1
TEL
0926426480
Homepage URL
tsukamoto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
KYUSHU UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
KYUSHU UNIVERSITY
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
Kyushu university hospital
Address
FUKUOKASHI, HIGASI-KU MAIDASHI 3-1-1
Tel
0926426480
tsukamoto@dent.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NOT APPLICABLE
Management information
Registered date
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057606
