UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002625 |
|---|---|
| Receipt number | R000003198 |
| Scientific Title | Portable EEG study of sleep status of patients with collagen vascular diseases. |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2010/10/13 17:17:03 |
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Basic information
Public title
Portable EEG study of sleep status of patients with collagen vascular diseases.
Acronym
EEG analysis of collagen vascular disease patients.
Scientific Title
Portable EEG study of sleep status of patients with collagen vascular diseases.
Scientific Title:Acronym
EEG analysis of collagen vascular disease patients.
Region
| Japan |
Condition
Condition
Rheumatoid disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
objective avaluation of sleep status of patients with collagen vascular disease who are under glucocorticoid therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between sleep status and EEG changes under glucocorticoid therapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with collagen vascular disease who are hospitalized in Kobe University Hospital or coming to outpatinet clinic at Kobe University Hospital.
Key exclusion criteria
1) patients who do not agree with this test.
2) patients whom their doctor do not think appropriate to enroll in this test.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawano Seiji |
Organization
Kobe University
Division name
Clinical Laboratory, Kobe University Hospital.
Zip code
Address
kusunoki-cho,chuo-ku,kobe,hyogo,japan
TEL
078-382-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawano Seiji |
Organization
Kobe University Hospital
Division name
Clinical Laboratory
Zip code
Address
kusunoki-cho,chuo-ku,kobe,hyogo,japan
TEL
078-382-5111
Homepage URL
sjkawano@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Clinical Laboratory. Kobe University Hospital.
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Laboratory. Kobe University Hospital.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Osaka Bioscience Institute. Sleepwell Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学医学部付属病院（兵庫県）
Kobe University Hospital (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | 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
Control study have finishide, and clinical study with patient samples has started.
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
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Enrollment began in December,2009.
Management information
Registered date
| 2009 | Year | 10 | Month | 13 | Day |
Last modified on
| 2010 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003198
