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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013924
Receipt No. R000016234
Scientific Title Impact of Continuous Positive Airway Pressure on Epicardial Adipose Tissue in Patients with Obstructive Sleep Apnea
Date of disclosure of the study information 2014/07/01
Last modified on 2017/05/11

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Basic information
Public title Impact of Continuous Positive Airway Pressure on Epicardial Adipose Tissue in Patients with Obstructive Sleep Apnea
Acronym Impact of CPAP on Epicardial Adipose Tissue in OSAS
Scientific Title Impact of Continuous Positive Airway Pressure on Epicardial Adipose Tissue in Patients with Obstructive Sleep Apnea
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo chin
Organization Graduate school of medicine, Kyoto University
Division name Resiratpry care and sleep control medicine
Zip code
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
1st name
Middle name
Last name Ryo Tachikawa
Organization Graduate school of medicine, Kyoto University
Division name Respiratory medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2014 Year 05 Month 10 Day
Date of IRB
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

Other
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

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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