UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038092 |
|---|---|
| Receipt number | R000043401 |
| Scientific Title | Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2019/09/25 04:39:50 |
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Basic information
Public title
Relationship between viral load and cough in elderly patients with influenza.
Acronym
Relationship between viral load and cough in elderly patients with influenza.
Scientific Title
Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection
Scientific Title:Acronym
Relationship between viral load and cough reflex sensitivity in elderly patients with influenza infection
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Influenza is a viral infection that should be emphasized in the elderly. This is particularly a problem for the elderly because many patients become severe with secondary bacterial pneumonia. The general clinical picture of influenza is as high as 38 to 40 degrees. However, as for cough symptoms in influenza patients, although there are previous studies in healthy adults, we have not conducted any studies in the elderly population so far. Not. Moreover, there is no report which investigated the amount of influenza viruses scattered with cough over time. Therefore, in this study, we investigate the amount of virus scattering due to influenza cough and changes over time in the cough reflex in elderly people.
Basic objectives2
Others
Basic objectives -Others
Change over time
Infection prevention
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cough frequency
Key secondary outcomes
Virus count
Cough impulse
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of elderly facilities who cooperate with research.
65 years old or older.
Key exclusion criteria
Unable to obtain consent for this research.
Problems with cognitive function such as dementia.
Using ventilators.
Severe dysphagia.
Having respiratory diseases such as asthma and cough asthma.
Those taking antitussives.
Unable to maintain a stable posture.
The doctor judged that participation in the research was difficult, such as severe flu symptoms.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | MASAHIRO |
| Middle name | |
| Last name | KOZUKI |
Organization
Tohoku University School of Medicine
Division name
Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai
TEL
022-717-7353
kohzukip@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | KENJI |
| Middle name | |
| Last name | MURAKAMI |
Organization
Tohoku University School of Medicine
Division name
Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai
TEL
022-717-7353
Homepage URL
k_murakami@seiyogakuin.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine.
Internal Medicine and Rehabilitation Science.
Institute
Department
Personal name
Funding Source
Organization
Sendai Medical Center Virus Research Center.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Sendai Medical Center Virus Research Center.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine Ethics Review Committee
Address
1-2 Seiryocho, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
仙台医療センター(宮城県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design.
Longitudinal observational study.
This study investigates changes in cough reflexes,cough impulses,and coughre leased virus levels over time due to inf luenza infection.
Research subjects.
Cohort senior citizens who are deemed suitable for subjects in medical facilities.
Measurement item.
Cough reflex caused by citric acid inhalation.
Presence or absence of cough impulse.
Number of viruses in cough.
Functional Independence Measure.
Grip strength.
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043401
