UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062708 |
|---|---|
| Receipt number | R000070203 |
| Scientific Title | A Prospective Multicenter Study on Episodic Nocturnal Hypercapnia in Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/27 12:18:28 |
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Basic information
Public title
A Prospective Multicenter Study on Episodic Nocturnal Hypercapnia in Chronic Obstructive Pulmonary Disease
Acronym
eNH study
Scientific Title
A Prospective Multicenter Study on Episodic Nocturnal Hypercapnia in Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
eNH study
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate whether the presence of episodic nocturnal hypercapnia (eNH), which reflects hypoventilation associated with REM sleep, influences future exacerbation risk and prognosis in patients with stable chronic obstructive pulmonary disease (COPD).
Basic objectives2
Others
Basic objectives -Others
Evaluation of exacerbation risk and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annualized frequency of moderate or severe exacerbations during the first year
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age >=40 years
2) Stable chronic obstructive pulmonary disease (COPD)
3) GOLD stage III-IV
4) Clinically stable condition without exacerbation for at least 2 weeks at enrollment
5) Daytime PaCO2 < 55 mmHg
6) CAAT score >=10 or mMRC grade >=2
Key exclusion criteria
1) Current use of home oxygen therapy, home high-flow therapy, home NIV, or home CPAP
2) Previous diagnosis or history of obstructive sleep apnea
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motonari |
| Middle name | |
| Last name | Fukui |
Organization
Medical Research Institute KITANO HOSPITAL
Division name
Respiratory Disease Center
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
81-6-6312-8831
mfukui@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Kitajima |
Organization
Medical Research Institute KITANO HOSPITAL
Division name
Respiratory Disease Center
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
81-6-6312-8831
Homepage URL
m-kitajima@kitano-hp.or.jp
Sponsor or person
Institute
Medical Research Institute KITANO HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
Medical Research Institute KITANO HOSPITAL
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.ac.jp
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
| 2026 | Year | 08 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The association between eNHI and COPD exacerbations will be prospectively evaluated.
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070203
