UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023323 |
|---|---|
| Receipt number | R000026865 |
| Scientific Title | Analysis of parasympathetic nerve dysfunction during night in overlap syndrome with obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) |
| Date of disclosure of the study information | 2016/07/25 |
| Last modified on | 2018/01/27 00:26:47 |
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Basic information
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
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
| 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
yamaguc@sirius.ocn.ne.jp
Public contact
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
yamaguc@sirius.ocn.ne.jp
Sponsor or person
Institute
Comprehensive Medical Center of Sleep Disorders, Tokyo Women's Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026865
