UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020195 |
|---|---|
| Receipt number | R000023324 |
| Scientific Title | Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2015/12/22 10:39:08 |
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Basic information
Public title
Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea
Acronym
Flexible PAP for OSA
Scientific Title
Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea
Scientific Title:Acronym
Flexible PAP for OSA
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
objective CPAP adherence after 3 months of CPAP treatment(objective adherence are downloaded and reported by the memory card located in the CPAP device.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
APAP(3 months)
Interventions/Control_2
C-flex(3 months)
Interventions/Control_3
A-flex(3 months)
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
Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.
Key exclusion criteria
Subjects diagnosed with CSA by overnight polysomnography.
Subjects ever used CPAP for OSA.
Target sample size
93
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
Departments of Respiratory Care and Sleep Control Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-Ku, Kyoto 606-8507, Japan.
TEL
075-751-3852
chink@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Chin |
Organization
Kyoto University Graduate School of Medicine
Division name
Departments of Respiratory Care and SleepControl Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-Ku, Kyoto 606-8507, Japan.
TEL
075-751-3852
Homepage URL
chink@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The 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
YES
Study ID_1
NCT00873977
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | 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
Management information
Registered date
| 2015 | Year | 12 | Month | 14 | Day |
Last modified on
| 2015 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023324
