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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034263
Receipt No. R000039066
Scientific Title Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA
Date of disclosure of the study information 2018/09/25
Last modified on 2018/09/25

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Basic information
Public title Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA
Acronym OSA merger rate in asthma
Scientific Title Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA
Scientific Title:Acronym OSA merger rate in asthma
Region
Japan

Condition
Condition Bronchial Asthma/Obstructive Sleep Apnea
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify OSA merger rate in bronchial asthma and biomarkers for diagnosis and treatment of OSA-associated asthma
Basic objectives2 Others
Basic objectives -Others Survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes OSA merger rate in asthma
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 out-of-center sleep testing
one day
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Stable asthmatic patients
>=18 years old
Key exclusion criteria COPD, Lung Cancer, Interstitial Pneumonia,poorly controlled heart failure, neuromuscular disease
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Tobino
Organization Iizuka Hospital
Division name Respiratory medicine
Zip code
Address 3-83 Yoshiomachi,Iizuka Fukuoka
TEL 0948223800
Email mina0628mina@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mina Yasuda
Organization Iizuka Hospital
Division name Respiratory medicine
Zip code
Address 3-83 Yoshiomachi,Iizuka Fukuoka
TEL 0948223800
Homepage URL
Email mina0628mina@gmail.com

Sponsor
Institute department of respiratory medicine Iizuka Hospital
Institute
Department

Funding Source
Organization Department of respiratory medicine Iizuka Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 09 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 22 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
2018 Year 09 Month 25 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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