UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039914 |
|---|---|
| Receipt number | R000043997 |
| Scientific Title | Frequency of sleep apnea syndrome in patients with bronchial asthma |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2022/09/30 10:31:47 |
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Basic information
Public title
Frequency of sleep apnea syndrome in patients with bronchial asthma
Acronym
Frequency of sleep apnea syndrome in patients with bronchial asthma
Scientific Title
Frequency of sleep apnea syndrome in patients with bronchial asthma
Scientific Title:Acronym
Frequency of sleep apnea syndrome in patients with bronchial asthma
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep apnea syndrome is an exacerbating factor of bronchial asthma, but there are no reports that examined it in Japan, and the frequency of the complications is unknown. Therefore, a simple test for sleep apnea syndrome is performed on patients with bronchial asthma to examine the frequency of complications. At the same time, asthma severity, exacerbation frequency, health-related QOL, ACT (asthma control), SF-12 (comprehensive QOL), AHQ-Japan (asthma QOL), F-scale (GERD presence / absence), LCQ (Lester Cough questionnaire), ESS (sleepiness), PSQI (sleep quality), etc., and the relationship with them.
Basic objectives2
Others
Basic objectives -Others
Frequency of sleep apnea syndrome in patients with bronchial asthma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of sleep apnea syndrome in patients with bronchial asthma
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Asthma patients
Age limit: 20 to 80 years old
Outpatients who regularly visit our hospital for more than 2 months
No change or exacerbation in asthma treatment for past 2months
You can fill out the questionnaire yourself
Key exclusion criteria
There are other uncontrolled complications / comorbidities
Performing CPAP Treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Tanaka |
Organization
Kawasaki Medical School
Division name
Respiratory Medicine
Zip code
710-0192
Address
577 matsushima, Kurashiki city
TEL
086-462-1111
hitomi.tanaka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Tanaka |
Organization
Kawasaki Medical School
Division name
Respiratory Medicine
Zip code
701-0192
Address
577 matsushima, Kurashiki city
TEL
086-462-1111
Homepage URL
hitomi.tanaka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
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
Kawasaki Medical School ethics committee
Address
577 matsushima, Kurashiki city
Tel
086-464-1076
kmsrec@med.kawasaki-m.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
| 2020 | Year | 03 | Month | 23 | 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
102
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Paper in progress
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subject is an adult over 20 years old, and out-of-center sleep test is performed on patients with bronchial asthma. The recruitment period is when 200 cases are scheduled.
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043997
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
