UMIN-CTR Clinical Trial

Public title

Analysis of parasympathetic nerve dysfunction during night in overlap syndrome with obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD)

Acronym

Parasympathetic nerve dysfunction in overlap syndrome

Scientific Title

Analysis of parasympathetic nerve dysfunction during night in overlap syndrome with obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD)

Scientific Title:Acronym

Parasympathetic nerve dysfunction in overlap syndrome

Region

Japan

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

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiro Yamaguchi

Organization

Tokyo Women's Medical University

Division name

Comprehensive Medical Center of Sleep Disorders

Zip code

Address

8-1 Kawata-cho, Shinjuku-ku, Tokyo 162-8666, Japan

TEL

03-3353-8111

Email

yamaguc@sirius.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Kazuhiro Yamaguchi

Organization

Tokyo Women's Medical University

Division name

Comprehensive Medical Center of Sleep Disorders

Zip code

Address

8-1 Kawata-cho, Shinjuku-ku, Tokyo 162-8666, Japan

TEL

03-3353-8111

Homepage URL

Email

yamaguc@sirius.ocn.ne.jp

Institute

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

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Internal Medicine, Nihon Koukan Hospital
Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2016

Year

07

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

04

Month

01

Day

Date of IRB

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

Other related information

Registered date

2016

Year

07

Month

25

Day

Last modified on

2018

Year

01

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026865