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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032953
Receipt No. R000036674
Scientific Title Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Date of disclosure of the study information 2018/07/01
Last modified on 2018/06/12

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Basic information
Public title Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Acronym Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Scientific Title Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Scientific Title:Acronym Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Region
Japan

Condition
Condition Sleep apnea syndrome
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between Sleep apnea syndrome(SAS) and serum KL-6 level and the effect of Positive Airway Pressure treatment (CPAP) on its levels.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between sleep apnea syndrome(SAS) and serum KL-6 level, and the effect of CPAP treatment on its level 6 months after the start of treatment.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Positive Airway Pressure treatment (CPAP) for 6 months
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
10 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with sleep apnea syndrome who first visit a sleep clinic at our university hospital.
2)Patients with informed concent.
Key exclusion criteria 1)Patients with interstitial lung disease
2)Patients with hypoxemia (at awake resting SpO 2 <95%)
3)Patients with infectious pneumonia or drug pneumonia or advanced stage cancer or pulmonary tuberculosis or alveolar proteinosis.
4)Patients in a state of shock
5)Patients with disturbance of consciouness
6)Patients on a ventilator
7)patients who are cnsiderded unsuitable for the trial by attending physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenjirou Wasano
Organization Kurume University school of medicine
Division name Depertment of Neuropsychiatry
Zip code
Address 67 Asahi-machi,Kurume,Fukuoka,Japan
TEL +81-942-31-7564
Email wasano_kenjirou@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenjirou Wasano
Organization Kurume University school of medicine
Division name Depertment of Neuropsychiatry
Zip code
Address 67 Asahi-machi,Kurume,Fukuoka,Japan
TEL +81-942-31-7564
Homepage URL
Email wasano_kenjirou@med.kurume-u.ac.jp

Sponsor
Institute Kurume University school of medicine,Depertment of Neuropsychiatry
Institute
Department

Funding Source
Organization Kurume University school of medicine,Depertment of Neuropsychiatry
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
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
2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 12 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036674

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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