UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008246 |
|---|---|
| Receipt number | R000009597 |
| Scientific Title | Influence of the CPAP (continuous positive airway pressure) on the nocturnal frequency in patients with SAS (the sleep apnea syndrome): analysis on its usefulness and underlying mechanisms |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2014/01/23 15:48:57 |
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Basic information
Public title
Influence of the CPAP (continuous positive airway pressure) on the nocturnal frequency in patients with SAS (the sleep apnea syndrome): analysis on its usefulness and underlying mechanisms
Acronym
Effect of the CPAP treatment on the nocturnal frequency in patients with the sleep apnea syndrome
Scientific Title
Influence of the CPAP (continuous positive airway pressure) on the nocturnal frequency in patients with SAS (the sleep apnea syndrome): analysis on its usefulness and underlying mechanisms
Scientific Title:Acronym
Effect of the CPAP treatment on the nocturnal frequency in patients with the sleep apnea syndrome
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Pneumology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of CPAP treatment on nocturnal frequency and to investigate underlying mechanisms including change in ADH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in nocturnal frequency after CPAP treatment
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing polysomnography due to suspicious diagnosis of SAS
Key exclusion criteria
1)Patients with active urinary tract infection, urolithiasis, or interstitial cystitis
2)Patients with bladder tumor to be treated or previously treated
3)Patients with a history of prostatectomy or radiotherapy
4)Patients treated with diuretics
5)Patients with serious complications such as cardiovascular disease, diabetes mellitus in poor control, liver disease, renal disease, immune system disease, lung disease or malignant tumor
6)Women in pregnancy or nursing, or women who wish to be pregnant during study participation
7)Patients judged to be inappropriate for this study by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Miyauchi |
Organization
KKR Takamatsu Hospital
Division name
Department of Urology
Zip code
Address
4-18 tenjinmae, Takamatsu
TEL
087-861-3261
miyauchi@kkr-ta-hp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Miyauchi |
Organization
KKR Takamatsu Hospital
Division name
Department of Urology
Zip code
Address
4-18 Tenjinmae, Takamatsu
TEL
087-861-3261
Homepage URL
miyauchi@kkr-ta-hp.gr.jp
Sponsor or person
Institute
KKR Takamatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
KKR Takamatsu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Urology ,Kagawa University Faculty of Medicine
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
KKR高松病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 25 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2014 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009597
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
