UMIN-CTR Clinical Trial

Basic information
Public title	Respiratory condition while sleeping and related factors in COPD patients
Acronym	Respiratory condition while sleeping and related factors in COPD patients
Scientific Title	Respiratory condition while sleeping and related factors in COPD patients
Scientific Title:Acronym	Respiratory condition while sleeping and related factors in COPD patients
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the respiratory condition while sleeping of COPD patients at home
Basic objectives2	Others
Basic objectives -Others	To investigate factors associated with respiratory condition while sleeping
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Apnea Hypopnea Index
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Nemuri scan (NN-1310) set for one week
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with diagnosis of COPD patients living at home
Key exclusion criteria	patients with an exacerbation in the previous 3 months
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Ishikawa
Organization	Kobe University
Division name	Graduate School of Health Sciences
Zip code	654-0142
Address	7-10-2 Tomogaoka,Suma-ku Kobe,Hyogo,Japan
TEL	078-796-4564
Email	ishikawa@bear-kobe.u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Ishikawa
Organization	Kobe University
Division name	Graduate School of Health Sciences
Zip code	654-0142
Address	7-10-2 Tomogaoka,Suma-ku Kobe,Hyogo,Japan
TEL	078-796-4564
Homepage URL
Email	ishikawa@bear.kobe-u.ac.jp

Sponsor
Institute	Kobe 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Health Science Ethics Committee
Address	7-10-2 Tomogaoka,Suma-ku Kobe,Hyogo,Japan
Tel	078-796-4502
Email	syomu2@ams.kobe-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	2020 Year 10 Month 12 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	2020 Year 01 Month 20 Day
Date of IRB	2020 Year 03 Month 24 Day
Anticipated trial start date	2020 Year 09 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 11 Day
Last modified on	2021 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047692