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

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 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


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

Value
https://center6.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