UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013924 |
|---|---|
| Receipt number | 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 21:29:24 |
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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
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
ryotkw@gmail.com
Sponsor or person
Institute
Graduate school of medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016234
