UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of continuous positive airway pressure (CPAP) on aortic aneurysms in patients with obstructive sleep apnea
Title of the study (Brief title)	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	Kazuo Chin
Organization	Graduate School of Medicine, Kyoto University
Division name	Respiratory Care and Sleep Control Medicine
Address	Shogoin 54, Kawahara-cho, Sakyo-Ku, Kyoto, Japan
TEL	81-(0)75-751-3852
Email	chink@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kazuo Chin
Organization	Graduate School of Medicine, Kyoto University
Division name	Respiratory Care and Sleep Control Medicine
Address	Shogoin 54, Kawahara-cho, Sakyo-Ku, Kyoto, Japan
TEL	81-(0)75-751-3852
Homepage URL	http://kukonai.com/office/class/
Email	ryotkw@gmail.com

Sponsor
Institute	Graduate School of Medicine, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 08 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013553