UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025002
Receipt number R000028511
Scientific Title Morbidity rates of sleep disordered breathing in patients with chronic obstructive pulmonary diseasee
Date of disclosure of the study information 2016/11/25
Last modified on 2022/06/14 14:01:51

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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 or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028511


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name