UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046828 |
|---|---|
| Receipt number | R000053407 |
| Scientific Title | Urinary eicosanoids and salivary stress hormones in patients with sleep-disordered breathing |
| Date of disclosure of the study information | 2022/02/04 |
| Last modified on | 2022/04/07 10:32:16 |
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Basic information
Public title
Urinary eicosanoids and salivary stress hormones in patients with sleep-disordered breathing
Acronym
Urinary eicosanoids and salivary stress hormones in patients with sleep-disordered breathing
Scientific Title
Urinary eicosanoids and salivary stress hormones in patients with sleep-disordered breathing
Scientific Title:Acronym
Urinary eicosanoids in patients with sleep-disordered breathing
Region
| Japan |
Condition
Condition
sleep disorder
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effects of sleep-disordered breathing on urinary eicosanoids and stress hormones during sleep
Basic objectives2
Others
Basic objectives -Others
Development of non-invasive indicators
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary eicosanoids
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted for PSG who agreed to the purpose of this study
Key exclusion criteria
Patients who are judged by the principal investigator to be unsuitable as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Wada |
Organization
Juntendo University
Division name
Faculty of Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
h-wada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Wada |
Organization
Juntendo University
Division name
Faculty of Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
Homepage URL
h-wada@juntendo.ac.jp
Sponsor or person
Institute
Department of Public Health,
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Public Health,
Juntendo University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Juntendo University
Address
2-1-1 Hongo, Bunkyo, Tokyo
Tel
03-3813-3111
N/A
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
| 2022 | Year | 02 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Uncontrolled, open-label, exploratory clinical trial
Method of recruitment of subjects
Patients visiting the clinic who are willing to participate in this study and have permission to use the data
Management information
Registered date
| 2022 | Year | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053407
