UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033746
Receipt number R000038493
Scientific Title Clinical trials of the safety and efficacy of strain sensors for cough
Date of disclosure of the study information 2018/10/01
Last modified on 2021/08/20 09:54:31

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Basic information

Public title

Clinical trials of the safety and efficacy of strain sensors for cough

Acronym

Review of cough monitor

Scientific Title

Clinical trials of the safety and efficacy of strain sensors for cough

Scientific Title:Acronym

Review of cough monitor

Region

Japan


Condition

Condition

Respiratory disease

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine safety and efficacy as cough monitor of strain sensor against cough.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

<First stage>
Determination of optimum application site
Determination of definition of cough waveform
<Second stage>
Measurement of coughing frequency

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Strain sensor

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

<First stage>
1. Subjects over 20 years old
2. Written informed consent
<Second stage>
1. Subjects over 20 years old
2. Patients with respiratory diseases with cough
3. Written informed consent

Key exclusion criteria

<First stage>
1. Subjects judged inappropriate by the person in charge of this study
<Second stage>
1. An unstable person who developed cardiovascular disease within 3 months
2. Persons who have serious illness such as advanced cancer and have a life expectancy of less than 6 months
3. Case of PS3/4
4. Persons with active infections that require treatment
5. Wounds at wearing site
6. Skin disorder (psoriasis) requiring treatment at the site of attachment
7. Subjects judged inappropriate by the person in charge of this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Nagano

Organization

Kobe University Graduate School of Medicine

Division name

Division of Respiratory Medicine, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan

TEL

+81783825660

Email

tnagano@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Nagano

Organization

Kobe University Graduate School of Medicine

Division name

Division of Respiratory Medicine, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan

TEL

0783825660

Homepage URL


Email

tnagano@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 10 Month 01 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

2018 Year 08 Month 14 Day

Date of IRB

2018 Year 11 Month 06 Day

Anticipated trial start date

2018 Year 11 Month 06 Day

Last follow-up date

2021 Year 06 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 14 Day

Last modified on

2021 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name