UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of parasympathetic activity among overlap syndrome patients
Title of the study (Brief title)	Study of parasympathetic activity among overlap syndrome patients
Region	Japan

Condition
Condition	COPD-OSA Overlap syndrome
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine of parasympathetic activity and lung function among COPD alone, OSA alone, and overlap syndrome patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	parasympathetic activity from PSG test
Key secondary outcomes	lung function from spirometry test

Base
Study type

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Overlap syndrome: CPAP treatment, every night, more than 4 hours a day, over 3 months.
Interventions/Control_2	OSA alone: CPAP treatment, every night, more than 4 hours a day, over 3 months.
Interventions/Control_3	COPD alone: continue usual COPD treatment.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Overlap syndrome: Japanease, over 40 years old, FEV1/EVC<70% from spirometry test, and AHI over 5 from PSG test. COPD alone: Japanease, over 40 years old, FEV1/EVC<70% from spirometry test, and AHI under 5 from PSG test. OSA alone: Japanease, over 40 years old, FEV1/EVC over 70% from spirometry test, and AHI over 5 from PSG test.
Key exclusion criteria	Patients who have diseases other than COPD which affect on the lung functional test. Patients who have markedly bad general condition.
Target sample size	60

Research contact person
Name of lead principal investigator	Koichi Fukunaga
Organization	Keio University, School of Medicine
Division name	Pulmonary medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3793
Email	k-fuku@jf7.so-net.ne.jp

Public contact
Name of contact person	Koichi Fukunaga
Organization	Keio University, School of Medicine
Division name	Pulmonary medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3793
Homepage URL
Email	k-fuku@jf7.so-net.ne.jp

Sponsor
Institute	Keio University, School of Medicine, Division of Pulmonary Medicine
Institute
Department

Funding Source
Organization	no
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	2015 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 26 Day
Anticipated trial start date	2015 Year 03 Month 13 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 20 Day
Last modified on	2017 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021354