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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020202
Receipt No. R000023332
Scientific Title Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
Date of disclosure of the study information 2015/12/15
Last modified on 2015/12/22

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Basic information
Public title Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
Acronym Circadian Variations of Prostaglandin in Sleep Apnea
Scientific Title Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
Scientific Title:Acronym Circadian Variations of Prostaglandin in Sleep Apnea
Region
Japan

Condition
Condition Obstructive Sleep Apnea
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of prostaglandins in the urine and blood before and after 2 days of CPAP treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 CPAP(2 days)
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 Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.
Key exclusion criteria Subjects treating for acute infections or malignancy.
Subjects with severe cardiovascular disease, diabetes,and renal failure.
Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Chin
Organization Kyoto University Graduate School of Medicine
Division name Departments of Respiratory Care and Sleep Control Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-Ku, Kyoto 606-8507, Japan.
TEL 075-751-3852
Email chink@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Chin
Organization Kyoto University Graduate School of Medicine
Division name Departments of Respiratory Care and Sleep Control Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-Ku, Kyoto 606-8507, Japan.
TEL 075-751-3852
Homepage URL
Email chink@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01096433
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
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 Completed
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 15 Day
Last modified on
2015 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023332

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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