UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055607 |
|---|---|
| Receipt number | R000063545 |
| Scientific Title | A study of sleep disorders in patients with chronic pain using actigraphy and sleep diaries. |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2024/09/24 23:39:02 |
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Basic information
Public title
A study of sleep disorders in patients with chronic pain using actigraphy and sleep diaries.
Acronym
A study of sleep disorders in patients with chronic pain using actigraphy and sleep diaries.
Scientific Title
A study of sleep disorders in patients with chronic pain using actigraphy and sleep diaries.
Scientific Title:Acronym
A study of sleep disorders in patients with chronic pain using actigraphy and sleep diaries.
Region
| Japan |
Condition
Condition
Patients with chronic pain
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the subjective and objective aspects of sleep disorders in patients with chronic pain using actigraphy and sleep diaries.
Basic objectives2
Others
Basic objectives -Others
To investigate whether sleep disorders and pain are bidirectionally related in patients with chronic pain.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Bidirectional relationship between pain intensity and sleep parameters
Key secondary outcomes
Sleep satisfaction, sleep efficiency, sleep onset latency, total sleep time, wake time after sleep onset
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been suffering from chronic pain for more than 3 months at the time of obtaining consent
2) Patients who are 18 years of age or older at the time of obtaining consent
3) Gender irrelevant
4) Patients who have received a sufficient explanation of their participation in this study, fully understood the information, and voluntarily provided written consent
Key exclusion criteria
1) Patients whose pain intensity was less than 3 on the Numerical Rating Scale (NRS) at the examination on the day of consent acquisition.
2) Patients with psychiatric disorders that have a clear impact on pain and sleep.
3) Patients with irregular sleep habits due to their occupation (e.g., three-shift work).
4) Patients who work in jobs that do not allow them to wear an actigraph during the day (e.g., cleaning operations, civil engineering work).
5) Patients who are unable to keep a sleep diary.
6) Patients who are otherwise deemed inappropriate as study subjects by the principal investigator (co-investigator).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Harada |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture
TEL
0836-22-2291
hdnrhrd@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Harada |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture
TEL
0836-22-2291
Homepage URL
hdnrhrd@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Scholarship donations for the Department of Anesthesiology, Yamaguchi University Graduate School of Medicine
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-057
Org. issuing International ID_1
Yamaguchi University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 25 | 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
36
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063545
