UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024193 |
|---|---|
| Receipt number | 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 08:45:33 |
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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
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
mienon@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University respiratory medicine department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027850
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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