UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of parasympathetic nerve dysfunction during night in overlap syndrome with obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD)
Title of the study (Brief title)	Parasympathetic nerve dysfunction in overlap syndrome
Region	Japan

Condition
Condition	Overlap syndrome with obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To clarify nighttime parasympathetic nerve dysfunction in OSA, COPD, and Overlap syndrome 2) To elucidate the PAP-induced improvement of nighttime parasympathetic nerve dysfunction in OSA and Overlap syndrome 3) To examine the improvement of lung function by PAP-elicited recovery of parasympathetic nerve dysfunction in Overlap syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of airflow limitation by continuous PAP therapy in Overlap syndrome
Key secondary outcomes	1) Nighttime parasympathetic nerve activity and stability estimated by instantaneous time-frequency analysis in OSA, COPD, and Overlap syndrome 2) Improvement of nighttime parasympathetic nerve activity and stability by PAP therapy in OSA and Overlap syndrome

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	No therapy for 6 months
Interventions/Control_2	Continuous positive airway pressure (PAP) treatment only for 6 months
Interventions/Control_3	Inhaled bronchodilators only for 6 months
Interventions/Control_4	Continuous positive airway pressure (PAP) treatment + inhaled bronchodilators for 6 months
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	OSA: age: more than 40 years old, FEV1/FVC: more than 70% after bronchodilator inhalation, and AHI: more than 20 events/hour COPD: age: more than 40 years old, FEV1/FVC: less than 70% after bronchodilator inhalation, and AHI: less than 10 events/hour Overlap syndrome: age: more than 40 years old, FEV1/FVC: less than 70% after bronchodilator inhalation, and AHI: more than 20 events/hour
Key exclusion criteria	Central sleep apnea (CSA) predominating over OSA Periodic leg movement disorders Atrial fibrillation, artificial cardiac rhythms by pacemakers, significant ectopic beats Severe systemic diseases, including malignancy in any organ, severe heart failure, heart attack or stroke, renal failure requiring dialysis, and impaired cognitive function
Target sample size	400

Research contact person
Name of lead principal investigator	Kazuhiro Yamaguchi
Organization	Tokyo Women's Medical University
Division name	Comprehensive Medical Center of Sleep Disorders
Address	8-1 Kawata-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL	03-3353-8111
Email	yamaguc@sirius.ocn.ne.jp

Public contact
Name of contact person	Kazuhiro Yamaguchi
Organization	Tokyo Women's Medical University
Division name	Comprehensive Medical Center of Sleep Disorders
Address	8-1 Kawata-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL	03-3353-8111
Homepage URL
Email	yamaguc@sirius.ocn.ne.jp

Sponsor
Institute	Comprehensive Medical Center of Sleep Disorders, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Internal Medicine, Nihon Koukan Hospital Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
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	東京女子医科大学睡眠総合診療センター 日本鋼管病院内科 慶應義塾大学病院呼吸器内科

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 28 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 25 Day
Last modified on	2018 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026865