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
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
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
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
