UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006924 |
|---|---|
| Receipt number | R000008160 |
| Scientific Title | Relationship between activity in heme oxygenase-1 (HO-1) and risk factors for cardiovascular diseases in patients with obstructive sleep apnea (OSA) |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2015/01/30 14:04:00 |
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Basic information
Public title
Relationship between activity in heme oxygenase-1 (HO-1) and risk factors for cardiovascular diseases in patients with obstructive sleep apnea (OSA)
Acronym
Relationship between activity in heme oxygenase-1 (HO-1) and risk factors for cardiovascular diseases in patients with obstructive sleep apnea (OSA)
Scientific Title
Relationship between activity in heme oxygenase-1 (HO-1) and risk factors for cardiovascular diseases in patients with obstructive sleep apnea (OSA)
Scientific Title:Acronym
Relationship between activity in heme oxygenase-1 (HO-1) and risk factors for cardiovascular diseases in patients with obstructive sleep apnea (OSA)
Region
| Japan |
Condition
Condition
Obstructive sleep apnea syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research for effects of HO-1 activity during sleep on vascular endothelial dysfunction, arteriosclerosis, and impaired glucose tolerance in patients with obstructive sleep apnea
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between changes in fraction of carbon monoxide (CO) during sleep and degrees of vascular endothelial dysfunction, intima media thickness, glucose intolerance, heart function, and proBNP
Key secondary outcomes
Association between severity of obstructive sleep apnea (OSA) and fraction of CO, vascular endothelial dysfunction, glucose intolerance, postprandial lipid metabolism, heart function, proBNP, and serum and urinary biomarkers
Changes in fraction of CO, vascular endothelial dysfunction, glucose intolerance, postprandial lipid metabolism, heart function, proBNP, and serum and urinary biomarkers in patients with OSA before and after CPAP treatment
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
Continuous positive airway pressure
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 for polysomnography with suspected OSA
Key exclusion criteria
*Smoker
*Patients with smoking history within 6 months
*Patients with chronic pulmonary disease (Bronchial asthma, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, etc)
*Patients under treatment for acute infection disease or malignant disease
*Patients who cannot take a meal tolerance test
Target sample size
80
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
Respiratory Care and Sleep Control Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Azuma |
Organization
Kyoto University Graduate School of Medicine
Division name
Departmet of Respiratory Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3852
Homepage URL
mazu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto 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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 21 | 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
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
| 2011 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 21 | Day |
Last modified on
| 2015 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008160
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
