UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001931 |
|---|---|
| Receipt number | R000002352 |
| Scientific Title | Multicenter epidemiological study for patients with obesity hypoventilation syndrome |
| Date of disclosure of the study information | 2009/05/01 |
| Last modified on | 2015/01/15 16:30:32 |
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Basic information
Public title
Multicenter epidemiological study for patients with obesity hypoventilation syndrome
Acronym
Study for OHS
Scientific Title
Multicenter epidemiological study for patients with obesity hypoventilation syndrome
Scientific Title:Acronym
Study for OHS
Region
| Japan |
Condition
Condition
Obstructive sleep apnea syndrome (OSAS) and/or Obesity hypoventilation syndrome (OHS)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) Research for effectiveness of CPAP treatment in patients with OHS
2) Research for severe obese subjects without OSAS
3) Estimation of number of patients with OHS newly starting CPAP
4) Research for the prevalence of OHS in patients with OSA in Japan
5) Research for the determinants of PaCO2 levels in patients with OSA or obese OSA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Adherence of CPAP treatment in patients with OHS
2) number of patients with OHS newly receiving CPAP
3) The prevalence of OHS in patients with OSA in Japan
4) The determinants of PaCO2 levels in patients with OSA or obese OSA
Key secondary outcomes
1) Clinical estimation of severe obese subjects without OSAS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous positive airway pressure
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Patients with OSAS who start CPAP treatment after polysomnography.
*Subjects with BMI>30 who undergo polysomnography.
Key exclusion criteria
Patients or subjects who do not give their consent form.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Chin |
Organization
Kyoto University Graduate School of Medicine
Division name
Respiratory Care and Sleep Control Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3852
konai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Hamada |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3830
Homepage URL
sh1124@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
the Respiratory Failure Research Group from the Ministry of Health, Labour and Welfare, Japan
Institute
Department
Personal name
Funding Source
Organization
the Respiratory Failure Research Group from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | 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
Date of protocol fixation
| 2009 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002352
