UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CPAP use situation questionnaire research for obstructive sleep apnea syndrome patients
Title of the study (Brief title)	CPAP use situation questionnaire research for obstructive sleep apnea syndrome patients
Region	Japan

Condition
Condition	Obstructive sleep apnea syndrome
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Obstructive sleep apnea (OSAS) syndrome causes night hypoxemia. An obstruction of the respiratory tract repeats in oropharynx during sleep. The patient's quality of life decreases with daytime excessive sleepiness, fatigue and lack of vigilance because of a sleep disorder by sleeping frequent apnea, hypopnea.Sleep apnea syndrome has a close relation with cardiovascular disease. In addition, the patient becomes easy to cause a traffic accident and work-related accident. For treatment, continuously positive pressure breathing therapy is common. The continuously sustained positive pressure breathing therapy prevents the collapse of the pharynx by adding positive pressure to the respiratory tract during sleep. A CPAP is the only cure that the effectiveness to cardiovascular disease including a mind neurological function and the high blood pressure is proved in a previous study, but the patients are required to continue CPAP treatment for a long term because it is not radical treatment. In addition, the CPAP use of an average of five hours is required overnight more than five days a week to get an enough improvement effect. However, the side effects depend highly individual, and there are differences in continuation and adherence of the treatment.We thought that though the influence on life was clear, the difference of the understanding degree to the disease and the treatment of the patient might be related in the treatment compliance.Therefore we perform "the questionary survey about OSAS and the CPAP" to evaluate an association between disease understanding and treatment adherence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of CPAP adherence and questionnaire about understanding of disease.
Key secondary outcomes	The extraction of a questionnaire item participating in poor adherence. The odds ratio of a questionnaire item participating in poor adherence.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	For all the study participants, I instruct the basic knowledge about OSAS and the CPAP. The instruction contents use a brochure for A4 with an illustration made with easy words and perform it in outpatient department medical treatment orally for three minutes.
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	Patient during CPAP management for sleep apnea syndrome in sleep breathing disorder outpatient department of the Fujita Health University Hospital.
Key exclusion criteria	A patient of minority or there is not enough judgement; of the unconsciousness.
Target sample size	400

Research contact person
Name of lead principal investigator	Kazuyoshi Imaizumi
Organization	Fujita Health University
Division name	Respiratory medicine department
Address	1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
TEL	+81-0562-93-9241
Email	mienon@fujita-hu.ac.jp

Public contact
Name of contact person	Yuki Mieno
Organization	Fujita Health University
Division name	Respiratory medicine department
Address	1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
TEL	+81-0562-93-9241
Homepage URL
Email	mienon@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University respiratory medicine department
Institute
Department

Funding Source
Organization	Fujita Health University respiratory medicine department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 30 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 02 Month 28 Day
Date trial data considered complete	2018 Year 06 Month 30 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 27 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027850