UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058158 |
|---|---|
| Receipt number | R000066476 |
| Scientific Title | Survey of the prevalence of postoperative sleep disorders |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/12 11:07:51 |
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Basic information
Public title
Survey of the prevalence of postoperative sleep disorders
Acronym
Survey of the prevalence of postoperative sleep disorders
Scientific Title
Survey of the prevalence of postoperative sleep disorders
Scientific Title:Acronym
Survey of the prevalence of postoperative sleep disorders
Region
| Japan |
Condition
Condition
Patients who underwent general anesthesia surgery within two weeks after approval by the Ethics Committee of Kinki University Faculty of Medicine
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of sleep disorders after surgery
Basic objectives2
Others
Basic objectives -Others
To investigate differences in the incidence of sleep disorders based on Richards-Campbell Sleep Questionnaire scores across categorized surgical sites and procedures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Findings on the incidence of postoperative sleep disorders based on scores from the Richards-Campbell Sleep Questionnaire
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent general anesthesia surgery within two weeks after approval by the Ethics Committee of Kinki University Faculty of Medicine
Key exclusion criteria
Missing data
Age under 18 years
Cognitive impairment
Returned to the ward postoperatively without extubation and under sedation
Individuals who expressed their intention to decline participation in this study via opt-out
Any other individuals deemed unsuitable for participation in this study by the principal investigator
Target sample size
246
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | MINO |
Organization
Kindai University Hospital
Division name
Department of Nurse anesthetist and Nurse practitioner
Zip code
589-8511
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
(072)366-0206
takashi.mino@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | MINO |
Organization
Kindai University Hospital
Division name
Department of Nurse anesthetist and Nurse practitioner
Zip code
589-8511
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
(072)366-0206
Homepage URL
takashi.mino@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai 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
Kindai Hospital Global Research Alliance Center
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
Tel
(072)366-0206
khgrac.info@med.kindai.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 | 07 | 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
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066476
