UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042074
Receipt number R000047692
Scientific Title Respiratory condition while sleeping and related factors in COPD patients
Date of disclosure of the study information 2020/10/12
Last modified on 2021/10/17 21:05:58

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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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047692


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name