UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Title of the study (Brief title)	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	Kenjirou Wasano
Organization	Kurume University school of medicine
Division name	Depertment of Neuropsychiatry
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	Kenjirou Wasano
Organization	Kurume University school of medicine
Division name	Depertment of Neuropsychiatry
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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