UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024127 |
|---|---|
| Receipt number | R000027780 |
| Scientific Title | The effect of four seasons on adherence with continuous positive airway pressure therapy for patients of obstructive sleep apnea. |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2020/10/01 19:49:14 |
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Basic information
Public title
The effect of four seasons on adherence with continuous positive airway pressure therapy for patients of obstructive sleep apnea.
Acronym
The effect of four seasons on adherence with continuous positive airway pressure therapy for patients of obstructive sleep apnea.
Scientific Title
The effect of four seasons on adherence with continuous positive airway pressure therapy for patients of obstructive sleep apnea.
Scientific Title:Acronym
The effect of four seasons on adherence with continuous positive airway pressure therapy for patients of obstructive sleep apnea.
Region
| Japan |
Condition
Condition
Obstructive sleep apnea (OSA)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study clarifies the effect of the four seasons on the CPAP adherence of the OSAS patients in japan.
Basic objectives2
Others
Basic objectives -Others
Seasonal validation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rates for CPAP use per month;(CPAP use days/month;%)
Key secondary outcomes
1)The rates for CPAP use>4hours at night per month(%).
2)The apnea-hypopnea index(AHI) average.
3)Questionnaire data about Bedroom environment.
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
#Patients who agree with this study
#The patient who were introduced CPAP therapy for diagnosis of obstructive sleep apnea.
#Those who were 12 months or more elapsed from the initiation of CPAP
#The patient in response to a questionnaire.
#The patients using CPAP machine of REM star Auto System One serie of Philips Respironics.
Key exclusion criteria
#Subjects whose experience to use CPAP was less than twelve months after initiating CPAP therapy.
#Subjects with impaired cognitive function.
#Subjects cannot operate the CPAP machine by oneself.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Wakamura |
Organization
Graduate school of medicine, Kyoto University
Division name
Human Health Science
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
81-(0)75-751-3974
wakamura.tomoko.5v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Wakamura |
Organization
Graduate school of medicine, Kyoto University
Division name
Human Health Science
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
81-(0)75-751-3974
Homepage URL
wakamura.tomoko.5v@kyoto-u.ac.jp
Sponsor or person
Institute
Graduate school of medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medicine, Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University Hospital
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
愛媛大学医学部附属病院（愛媛県） Ehime University hospital(Ehime prefecture)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 12 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2016 | Year | 09 | Month | 21 | Day |
Last modified on
| 2020 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027780
