UMIN-CTR Clinical Trial

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
Email	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
Email	hitomi.tanaka@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043997