UMIN-CTR Clinical Trial

Basic information
Public title	Morbidity rates of sleep disordered breathing in patients with chronic obstructive pulmonary diseasee
Acronym	Sleep disordered breathing in COPD
Scientific Title	Morbidity rates of sleep disordered breathing in patients with chronic obstructive pulmonary diseasee
Scientific Title:Acronym	Sleep disordered breathing in COPD
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the morbidity rate of sleep disordered breathing in patients with chronic obstructive pulmonary disease using ambulatory pulse oximetry monitoring.
Basic objectives2	Others
Basic objectives -Others	To decide the adaptation of home oxygen therapy and non-invasive positive pressure ventilation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the morbidity rate of sleep disordered breathing
Key secondary outcomes	Comparison of the following indices in the presence or absence of hypoxemia due to low ventilation at night 1. PaO2, PaCO2 2. Pulmonary function tests 3. %LAA, air trapping 4. Number of acute exacerbations and hospitalizations 5. Health related QOL 6. BMI 7. Symptoms.

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. COPD was diagnosed based on the guidelines for the diagnosis and treatment of COPD, 4th Edition. 2. Ex-smoker 3. Patients who are stable for more than 4 weeks without exacerbation events related to COPD 4. Outpatient
Key exclusion criteria	1. Patients with arterial blood gas pH <7.30 2. Systemic administration of steroids 3. Patients prescribed home oxygen therapy and positive pressure therapy 4. Serious complications such as malignant diseases, heart diseases, liver diseases and renal disorders 5. Patients who may be pregnant.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Nishine
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan
TEL	044-977-8111
Email	h2nishine@marianna-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Nishine
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
TEL	044-977-8111
Homepage URL
Email	h2nishine@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Graduate Student Affairs and Research Promotion
Address	2-16-1 Sugao, Miyamae-ku, Kawas aki, Japan 216-8511
Tel	044-977-8111
Email	k-sienbu.mail@marianna-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	2016 Year 11 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	Terminated
Date of protocol fixation	2016 Year 07 Month 19 Day
Date of IRB	2016 Year 07 Month 19 Day
Anticipated trial start date	2016 Year 11 Month 24 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2016 Year 11 Month 25 Day
Last modified on	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028511