UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037793 |
|---|---|
| Receipt number | R000043098 |
| Scientific Title | CPAP for sleep apnea syndrome; relationship between adherence and health literacy |
| Date of disclosure of the study information | 2019/08/24 |
| Last modified on | 2023/02/25 13:20:10 |
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Basic information
Public title
CPAP for sleep apnea syndrome; relationship between adherence and health literacy
Acronym
CPAP for sleep apnea syndrome; relationship between adherence and health literacy
Scientific Title
CPAP for sleep apnea syndrome; relationship between adherence and health literacy
Scientific Title:Acronym
CPAP for sleep apnea syndrome; relationship between adherence and health literacy
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research for relationship between CPAP adherence treating for sleep apnea syndrome and health literacy
Basic objectives2
Others
Basic objectives -Others
research relationshop
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between CPAP average using time and HLS-EU-Q47 score
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Who use CPAP for sleep apnea syndrome first time
Who agree with this research
Key exclusion criteria
Who don't agree with this research
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Masatomi |
| Middle name | |
| Last name | Ikusaka |
Organization
Chiba University Hospital
Division name
General Medicine
Zip code
260-8677
Address
Inohana 1-8-1, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
ahga4572@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Li |
Organization
Chiba University Hospital
Division name
General medicine
Zip code
260-8677
Address
Inohana 1-8-1, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
Homepage URL
ahga4572@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
Inohana 1-8-1, Chuo-ku, Chiba city, Chiba
Tel
0432227171
ahga4572@chiba-u.jp
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
| 2019 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.568
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jgf2.568
Number of participants that the trial has enrolled
51
Results
Please refer to the above URL
Results date posted
| 2023 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please refer to the above URL
Participant flow
Please refer to the above URL
Adverse events
None.
Outcome measures
Please refer to the above URL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No information
Management information
Registered date
| 2019 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043098
