UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025002 |
|---|---|
| Receipt number | R000028511 |
| Scientific Title | Morbidity rates of sleep disordered breathing in patients with chronic obstructive pulmonary diseasee |
| Date of disclosure of the study information | 2016/11/25 |
| Last modified on | 2022/06/14 14:01:51 |
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Basic information
Public title
Morbidity rates of sleep disordered breathing in patients with chronic obstructive pulmonary diseasee
Acronym
Sleep disordered breathing in COPD
Scientific Title
Morbidity rates of sleep disordered breathing in patients with chronic obstructive pulmonary diseasee
Scientific Title:Acronym
Sleep disordered breathing in COPD
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the morbidity rate of sleep disordered breathing in patients with chronic obstructive pulmonary disease using ambulatory pulse oximetry monitoring.
Basic objectives2
Others
Basic objectives -Others
To decide the adaptation of home oxygen therapy and non-invasive positive pressure ventilation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the morbidity rate of sleep disordered breathing
Key secondary outcomes
Comparison of the following indices in the presence or absence of hypoxemia due to low ventilation at night
1. PaO2, PaCO2
2. Pulmonary function tests
3. %LAA, air trapping
4. Number of acute exacerbations and hospitalizations
5. Health related QOL
6. BMI
7. Symptoms.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. COPD was diagnosed based on the guidelines for the diagnosis and treatment of COPD, 4th Edition.
2. Ex-smoker
3. Patients who are stable for more than 4 weeks without exacerbation events related to COPD
4. Outpatient
Key exclusion criteria
1. Patients with arterial blood gas pH <7.30
2. Systemic administration of steroids
3. Patients prescribed home oxygen therapy and positive pressure therapy
4. Serious complications such as malignant diseases, heart diseases, liver diseases and renal disorders
5. Patients who may be pregnant.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of
Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan
TEL
044-977-8111
h2nishine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
TEL
044-977-8111
Homepage URL
h2nishine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
Division of Graduate Student Affairs and Research Promotion
Address
2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2016 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028511
