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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028242
Receipt No. R000032322
Scientific Title The examination of sleep disoders in the patients with interstitial lung diseases
Date of disclosure of the study information 2017/12/01
Last modified on 2017/07/14

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Basic information
Public title The examination of sleep disoders in the patients with interstitial lung diseases
Acronym Sleep disoders in the patients with interstitial lung diseases
Scientific Title The examination of sleep disoders in the patients with interstitial lung diseases
Scientific Title:Acronym Sleep disoders in the patients with interstitial lung diseases
Region
Japan

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

Objectives
Narrative objectives1 To examine the prevalence of sleep disoders in the patients with interstitial lung diseases and to validate the efficacy of treating sleep apnea syndrome
Basic objectives2 Others
Basic objectives -Others To examine the QOL score in the patients with interstitial lung diseases and to assess the relevance between severity of lung disease and scores.To find predictors for successful sleep apnea treatments and reveal the relevance between treatments and prognosis.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes prevalence of sleep disorders and severity of QOL score in the patients with interstitial lung diseases at the beginning of the study, changes in QOL score by treating sleep apnea syndrome in the patients with interstitial lung diseases at 3,6,12,24 month after starting the study
Key secondary outcomes residual apnea-hypopnea index in the patients who took treatment of sleep apnea syndrome, prognosis, frequency of acute exacerbations of interstitial lung diseases at the point of 24 month after starting the study, changes in tricuspid valve regurgitation velocity by echocardiography at the point of 6 month after treatment of sleep apnea syndrome, changes in forced vital capacity and forced vital capacity percent predicted 6,12,24 after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 CPAP therapy for the patients with severe sleep apnea syndrome
Interventions/Control_2 oral appricance therapy for the patients with severe sleep apnea syndrome
Interventions/Control_3 without treatment for the patients with severe sleep apnea syndrome
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 patients with interstitial lung diseases who is over 20 years old
Key exclusion criteria patients who have already diagnosed as sleep apnea syndrome
Target sample size 125

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuma Kishi
Organization Toranomon Hospital
Division name respiratory centor
Zip code
Address 2-2-2,Toranomon,Minato-ku
TEL 0335881111
Email kaz_sap_tok@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Ogawa
Organization Toranomon Hospital
Division name respiratory centor
Zip code
Address 2-2-2,Toranomon,Minato-ku
TEL 03-3588-1111
Homepage URL
Email kaz.sap.tok@toranomon.gr.jp

Sponsor
Institute respiratory centor, Toranomon Hospital
Institute
Department

Funding Source
Organization Toranomon 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
2017 Year 12 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
2017 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2017 Year 07 Month 14 Day
Last modified on
2017 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032322

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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