UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051517 |
|---|---|
| Receipt number | R000058681 |
| Scientific Title | Assessment of Sleep Quality and Mobilization Using the Actigraph in Postoperative Patients with Esophageal Cancer: A Prospective Observational Study |
| Date of disclosure of the study information | 2023/07/04 |
| Last modified on | 2023/12/10 22:30:52 |
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Basic information
Public title
Assessment of Sleep Quality and Mobilization Using the Actigraph in Postoperative Patients with Esophageal Cancer: A Prospective Observational Study
Acronym
ACT study
Scientific Title
Assessment of Sleep Quality and Mobilization Using the Actigraph in Postoperative Patients with Esophageal Cancer: A Prospective Observational Study
Scientific Title:Acronym
ACT study
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Postoperative patients with esophageal cancer are known to have long-term insomnia, however, there are few reports on acute sleep disturbances and their impact in the perioperative period. The purpose of this study is to clarify the prevalence of sleep disturbances in the perioperative period of esophageal surgery in our hospital.
Basic objectives2
Others
Basic objectives -Others
Investigation of current status
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative score of The Richards-Campbell Sleep Questionnaire (RCSQ) for 4 postoperative days.
Key secondary outcomes
Numerical rating score of pain
CAM-ICU for 4 potoperative days
Length of ICU stay
Postoperative use of analgesics
Postoperative complications
Start date of postoperative mobilization
Parameters obtained by Actigraph for 14 postoperative days
Assessment of Quality of life using EQ-5D-5L
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
1. Patients scheduled for radical esophagectomy.
2. Patients who are 18 years old or older.
3. Patients who are able to obtain written consent for research participation of their own free will.
Key exclusion criteria
1. Patients who have difficulty wearing the Actigraph on their wrist for any reason (e.g., skin abnormalities).
2. Patients who have difficulty in answering the questionnaire in Japanese.
3. Patients who are currently participating in another prospective study and have been determined to have a potential impact on each other's study results.
4. patients who are deemed inappropriate as research subjects by the principal investigator or sub investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morimatsu |
Organization
Okayama University
Division name
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Anesthesiology and Resuscitology.
Zip code
700-0903
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7778
yoshikimura_16@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Kimura |
Organization
Okayama university
Division name
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of
Zip code
700-0903
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7778
Homepage URL
yoshikimura_16@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Anesthesiology and Resuscitology.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama University Graduate School of Interdisciplinary Science and Engineering in Health Systems, Department of Biomedical Informatics.
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterological Surgery.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
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
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate perioperative sleep disturbances in radical esophagectomy using the Richards-Campbell Sleep Questionnaire and Actigraph.
Management information
Registered date
| 2023 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058681
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
