UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011592 |
|---|---|
| Receipt number | R000013553 |
| Scientific Title | The impact of continuous positive airway pressure (CPAP) on aortic aneurysms in patients with obstructive sleep apnea |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2016/08/29 15:18:18 |
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Basic information
Public title
The impact of continuous positive airway pressure (CPAP) on aortic aneurysms in patients with obstructive sleep apnea
Acronym
The impact of CPAP on aortic aneurysms in patients with OSA
Scientific Title
The impact of continuous positive airway pressure (CPAP) on aortic aneurysms in patients with obstructive sleep apnea
Scientific Title:Acronym
The impact of CPAP on aortic aneurysms in patients with OSA
Region
| Japan |
Condition
Condition
obstructive sleep apnea
aortic aneurysm
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed at investigating whether CPAP therapy can attenuate aortic aneurysm expansion in patients with obstructive sleep apnea, in order to explore the causal relationship between aortic aneurysm expansion and obstructive sleep apnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in the expansion rate of aortic aneurysms (mm/year) before and after the CPAP treatment
Key secondary outcomes
1. Expansion rate (mm/year) of aortic aneurysms in patients without CPAP treatment
2. Prevalence of OSA in patients with aortic aneurysm
3. Events associated with aortic aneurysm
4. Cardiovascular events
5. Changes in biomarkers of aortic aneurysm
6. Changes in blood pressure and endothelial function
7. Changes in epicardial fat and visceral fat volume
8. Changes in sleep duration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with apnea-hypopnea index (AHI)>20
CPAP treatment (during sleep, everyday)
Interventions/Control_2
Patients with apnea-hypopnea index (AHI)<20
No treatment
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
1. Patients with thoracic aortic aneurysm (TAA) or abdominal aortic aneurysm (AAA)
2. Diameter of aortic aneurysm has been measured by CT for at least one year
3. Receiving appropriate treatments for hypertension, dyslipidemia, and/or diabetes
Key exclusion criteria
1. Previous or current treatments for sleep apnea.
2. Previous treatment for aortic aneurysm
3. Planned intervention for aortic aneurysm
4. Central sleep apnea syndrome
5. Long-term oxygen therapy
6. Aortic aneurysm associated with hereditary diseases (e.g. Marfan syndrome)
7. Unable to use CPAP
8. Hope for treatments other than CPAP for OSA
9. Surgery of upper airway within 90 days
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Chin |
Organization
Graduate School of Medicine, Kyoto University
Division name
Respiratory Care and Sleep Control Medicine
Zip code
Address
Shogoin 54, Kawahara-cho, Sakyo-Ku, Kyoto, Japan
TEL
81-(0)75-751-3852
chink@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Chin |
Organization
Graduate School of Medicine, Kyoto University
Division name
Respiratory Care and Sleep Control Medicine
Zip code
Address
Shogoin 54, Kawahara-cho, Sakyo-Ku, Kyoto, Japan
TEL
81-(0)75-751-3852
Homepage URL
http://kukonai.com/office/class/
ryotkw@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 01 | 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
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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 27 | Day |
Last modified on
| 2016 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013553
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