UMIN-CTR Clinical Trial

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
Institute	Kobe University Graduate School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038493