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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002625
Receipt No. 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

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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
Email

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
Email sjkawano@med.kobe-u.ac.jp

Sponsor
Institute Department of Clinical Laboratory. Kobe University Hospital.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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