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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024193
Receipt No. R000027850
Scientific Title CPAP use situation questionnaire research for obstructive sleep apnea syndrome patients
Date of disclosure of the study information 2017/02/01
Last modified on 2018/10/01

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Basic information
Public title CPAP use situation questionnaire research for obstructive sleep apnea syndrome patients
Acronym CPAP use situation questionnaire research for obstructive sleep apnea syndrome patients
Scientific Title CPAP use situation questionnaire research for obstructive sleep apnea syndrome patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuyoshi Imaizumi
Organization Fujita Health University
Division name Respiratory medicine department
Zip code
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
1st name
Middle name
Last name Yuki Mieno
Organization Fujita Health University
Division name Respiratory medicine department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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