UMIN-CTR Clinical Trial

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
Email	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
Email	h-wada@juntendo.ac.jp

Sponsor
Institute	Department of Public Health, Juntendo University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053407