UMIN-CTR Clinical Trial

Basic information
Public title	The prevalence of obstructive sleep apnea in patients with chronic obstructive pulmonary disease: meta-analysis
Acronym	The prevalence of obstructive sleep apnea in patients with chronic obstructive pulmonary disease: meta-analysis
Scientific Title	The prevalence of obstructive sleep apnea in patients with chronic obstructive pulmonary disease: meta-analysis
Scientific Title:Acronym	The prevalence of obstructive sleep apnea in patients with chronic obstructive pulmonary disease: meta-analysis
Region	Japan

Condition
Condition	COPD OSA
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the global prevalence of OSA in COPD patients
Basic objectives2	Others
Basic objectives -Others	prevalence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevalence
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The studies of OS written in English are collected. The prevalence of OS in COPD patients must be described. COPD patients must be diagnosed with spirometry and confirmed by the presence of a postbronchodilator forced expiratory volume in the 1st second/forced vital capacity (FEV1/FVC) < 70%. And OSA must be diagnosed according to AHI of PSG.
Key exclusion criteria	Non-English studies are not collected.
Target sample size

Research contact person
Name of lead principal investigator	1st name Nobuhiko Middle name Last name Fukuda
Organization	Yokohama City University Graduate School of Medicine, Yokohama, Japan
Division name	Department of Pulmonology
Zip code	236-0004
Address	Fukuura 3-9 Kanazawa-Ku, Yokohama, Kanagawa, Japan
TEL	0457872800
Email	e103066f@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Nobuhiko Middle name Last name Fukuda
Organization	Yokohama City University Graduate School of Medicine, Yokohama, Japan
Division name	Department of Pulmonology
Zip code	236-0004
Address	Fukuura 3-9 Kanazawa-Ku, Yokohama, Kanagawa, Japan
TEL	0457872800
Homepage URL
Email	e103066f@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
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	Yokohama City University
Address	Fukuura 3-9 Kanazawa-Ku, Yokohama, Kanagawa, Japan
Tel	0457872800
Email	e103066f@yokohama-cu.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	2022 Year 11 Month 21 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	Open public recruiting
Date of protocol fixation	2022 Year 08 Month 18 Day
Date of IRB	2022 Year 08 Month 18 Day
Anticipated trial start date	2022 Year 08 Month 18 Day
Last follow-up date	2022 Year 08 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study search Pubmed will be searched to identify eligible articles on August, 2022. The retrieval formula is as follows: Pubmed (COPD OR chronic obstructive pulmonary disease) AND (sleep apnea OR OSA OR SAS) AND (COPD[Title] OR chronic obstructive pulmonary disease[Title] OR sleep apnea[Title] OR OSA[Title] OR SAS[Title]) AND (prevalence OR epidemiology OR epidemiological OR epidemiologic OR population) Web of Science TI=(COPD OR chronic obstructive pulmonary disease OR sleep apnea OR OSA OR SAS) AND TS=(COPD OR chronic obstructive pulmonary disease) AND TS=(sleep apnea OR OSA OR SAS) AND TS=(prevalence OR epidemiology OR epidemiological OR epidemiologic OR population) Data extraction The characteristics (first author name, publication year, country, methods of diagnosis, gender, age, body mass index (BMI), spirometry date and sample size) of including studies and trial outcome with its 95% confidence interval (95% CI) are extracted by two authors (SM and NF). The extracted data is checked by two authors and final confirmation was done by a third author (NH). Statistical analyses The frequentist weighted least squares approach random-model network meta-analysis will be applied in our study8). Data are analyzed using Review Manager 5 software.

Management information
Registered date	2022 Year 11 Month 21 Day
Last modified on	2022 Year 11 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056459