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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034167
Receipt No. R000038935
Scientific Title Clinical Investigation of relationship between interstitial pneumonia complicated by obstructive sleep apnea and physical inactivity or short-term changes in blood pressure
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/16

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Basic information
Public title Clinical Investigation of relationship between interstitial pneumonia complicated by obstructive sleep apnea and physical inactivity or short-term changes in blood pressure
Acronym Interstitial pneumonia and obstructive sleep apnea
Scientific Title Clinical Investigation of relationship between interstitial pneumonia complicated by obstructive sleep apnea and physical inactivity or short-term changes in blood pressure
Scientific Title:Acronym Interstitial pneumonia and obstructive sleep apnea
Region
Japan

Condition
Condition interstitial pneumonia
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We clarify the frequency of complication of obstructive sleep apnea among patients with interstitial pneumonia. We also clarify the involvement of this complication in the physical inactivity or short-term change of blood pressure and treatment effects of CPAP.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Development of physical activity in 2 months after initiation of CPAP therapy in patients with interstitial pneumonia complicated by obstructive sleep apnea
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 For patients with interstitial pneumonia who were diagnosed as complicating obstructive sleep apnea, CPAP treatment is initiated.
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 Adult patients who are admitted for investigating the etiology of interstitial pneumonia
Key exclusion criteria Patients with acute exacerbation of interstitial pneumonia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meiyo Tamaoka
Organization Tokyo Medical and Dental University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-0000
Email meiyou2.pulm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Meiyo Tamaoka
Organization Tokyo Medical and Dental University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5954
Homepage URL
Email meiyou2.pulm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Hospital
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 10 Month 01 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
2018 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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
2018 Year 09 Month 16 Day
Last modified on
2018 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038935

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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