UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034167 |
|---|---|
| Receipt number | 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 | 2024/09/20 11:11:06 |
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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 | Meiyo |
| Middle name | |
| Last name | Tamaoka |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-0000
meiyou2.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Meiyo |
| Middle name | |
| Last name | Tamaoka |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5954
Homepage URL
meiyou2.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Hospital
Institute
Department
Personal name
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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5954
iizipulm@tmd.ac.jp
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
https://ndlsearch.ndl.go.jp/books/R000000004-I031849996
Publication of results
Published
Result
URL related to results and publications
https://ndlsearch.ndl.go.jp/books/R000000004-I031849996
Number of participants that the trial has enrolled
33
Results
The complication rate of sleep apnoea was high in interstitial pneumonia. The AHI was a determinant of physical activity assessed using the actigraph. It was not possible to show whether such physical activity improves with the introduction of CPAP.
Results date posted
| 2024 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with stable interstitial pneumonia who were admitted to the Department of Respiratory Medicine of the University Hospital for close examination and whose consent was obtained were included. Patients who were admitted urgently for treatment due to complications of pneumonia or acute exacerbation of interstitial pneumonia were excluded from the study.
Participant flow
In the above patients, the severity of interstitial pneumonia was assessed by pulmonary function tests of standardised effort lung capacity (%FVC), while activity was assessed by interstitial pneumonia markers such as KL-6 and SP-D, and CRP.
Adverse events
None
Outcome measures
Assessment of sleep-disordered breathing
Unsupervised nocturnal polysomnography was performed using a SomnoTouch RESP (Fukuda Lifetec) to record electroencephalography (EEG), electro-oculography (EOG), electromyography (EMG), electrocardiography, airflow, respiratory effort, oxygen saturation and lower limb movements (PM). Assessment items were apnoea-hypopnoea index (AHI), oxygen desaturation index (SpO2 index) and time below 90% drop (TST90). an AHI of more than 5 was considered a diagnosis of sleep apnoea, of which<15 was considered mild, <30 moderate and>30 severe. patients with an AHI >20 recorded were recommended continuous positive airway pressure (CPAP) ventilation in accordance with the guidelines for the treatment of sleep apnoea syndrome (SAS) (Japanese Respiratory Society) and started the same treatment if consent was obtained.
Assessment of physical activity
The Actigraph was used to assess physical activity during the day and night.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038935
