UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea
Title of the study (Brief title)	Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea
Region	Japan

Condition
Condition	obstructive sleep apnea
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the useful biomarkers to diagnosis and prognosis prediction in the patients with obstructive sleep apnea
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	microRNA in plasma
Key secondary outcomes	protein in plasma polysomnography

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	The patients consent to this investigation
Key exclusion criteria	The patients found to be inadequate by attending physicians for this investigation
Target sample size	200

Research contact person
Name of lead principal investigator	Norihisa Ito
Organization	Osaka university graduate School of medicine
Division name	The department of geriatric and general medicine
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3852
Email	itoh@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person	Norihisa Ito
Organization	Osaka university graduate School of medicine
Division name	The department of geriatric and general medicine
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3852
Homepage URL
Email	itoh@geriat.med.osaka-u.ac.jp

Sponsor
Institute	Osaka university graduate School of medicine The department of geriatric and general medicine
Institute
Department

Funding Source
Organization	Osaka university graduate School of medicine The department of geriatric and general medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 03 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	cohort study The objective is the patients consent to this investigation. Study duration is from Mar/16/2016 to Dec/31/2021. Investigation to miRNA in plasma, protein in plasma and polysomnography etc.

Management information
Registered date	2016 Year 03 Month 16 Day
Last modified on	2018 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024798