UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028242 |
|---|---|
| Receipt number | 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 16:47:17 |
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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
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
kaz.sap.tok@toranomon.gr.jp
Sponsor or person
Institute
respiratory centor, Toranomon Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032322
