UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017404 |
|---|---|
| Receipt number | R000020189 |
| Scientific Title | The Relationship Between Sleep Disordered Breathing and Airway Inflammation |
| Date of disclosure of the study information | 2015/05/04 |
| Last modified on | 2015/05/03 00:45:51 |
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Basic information
Public title
The Relationship Between Sleep Disordered Breathing and Airway Inflammation
Acronym
The Relationship Between Sleep Disordered Breathing and Airway Inflammation
Scientific Title
The Relationship Between Sleep Disordered Breathing and Airway Inflammation
Scientific Title:Acronym
The Relationship Between Sleep Disordered Breathing and Airway Inflammation
Region
| Japan |
Condition
Condition
Obstructive Sleep Apnea Syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether airway inflammation is induced in obstructive sleep apnea syndrome.
Basic objectives2
Others
Basic objectives -Others
Pathophysiological analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exhaled NO
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with obstructive sleep apnea syndrome
Key exclusion criteria
1)Patients receiving BA therapy
2)Patients presenting BA symptom
3)Patients with allergic rhinitis
4)Patients using inhaled or oral corticosteroids
5)Current smokers
6)Patients with hyperthyroidism, hypertension, heart diseases or diabetes who are not suitable for short-acting beta stimulant.
7)Inappropriate patients for this study judged by the physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Ogawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Occupational Health
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7874
ogawa-hiro@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Ogawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Occupational Health
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7874
Homepage URL
ogawa-hiro@m.tohoku.ac.jp
Sponsor or person
Institute
Department of Occupational Health, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 05 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study in which the relationship between parameters of sleep disordered breathing and exhaled NO is evaluated.
Management information
Registered date
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020189
