UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Continuous Positive Airway Pressure on Epicardial Adipose Tissue in Patients with Obstructive Sleep Apnea
Title of the study (Brief title)	Impact of CPAP on Epicardial Adipose Tissue in OSAS
Region	Japan

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

Objectives
Narrative objectives1	To investigate changes in the volume of epicardial adipose tissue (EAT) before and after CPAP treatment for obstructive sleep apnea (OSA), thereby exploring the causal relationship between OSA and EAT.
Basic objectives2	Others
Basic objectives -Others	The impact of CPAP on epicardial adipose tissue volume.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change in the volume of epicardial adipose tissue (measured by cardiac CT) during a 1-year CPAP treatment for OSA.
Key secondary outcomes	1. The change in body weight and body composition 2. The progression of coronary arterty disease 3. The recurrence of arrythmia 4. The change in leptin/adiponectin 5. The change in serum lipid level

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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Scheduled to undergo polysomnography 2. Cardiac CT is avairable
Key exclusion criteria	1. Current or previous treatments for obstructive sleep apnea 2. Central sleep apnea syndrome 3. Unable to use CPAP 4. Hope for treatments other than CPAP 5. Scheduled to have special treatment or program for body weight reduction 6. Wearing a pacemaker
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuo chin
Organization	Graduate school of medicine, Kyoto University
Division name	Resiratpry care and sleep control medicine
Address	Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3852
Email	chink@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Ryo Tachikawa
Organization	Graduate school of medicine, Kyoto University
Division name	Respiratory medicine
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto
TEL	075-751-3852
Homepage URL
Email	ryotkw@gmail.com

Sponsor
Institute	Graduate school of medicine, Kyoto University
Institute
Department

Funding Source
Organization	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)

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 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 10 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observational study The changes in epicardial adipose tissue volume measured by cardiac CT before and after 1-year CPAP treatment for obstructive sleep apnea will be investigated.

Management information
Registered date	2014 Year 05 Month 10 Day
Last modified on	2017 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016234