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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022133
Receipt No. R000025486
Scientific Title effects of tongue elevation and pushing has on the optional cough force
Date of disclosure of the study information 2016/12/01
Last modified on 2017/05/27

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Basic information
Public title effects of tongue elevation and pushing has on the optional cough force
Acronym study of cough
Scientific Title effects of tongue elevation and pushing has on the optional cough force
Scientific Title:Acronym study of cough
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of the method for increasing the optional cough force
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes peak cough flow
Key secondary outcomes age,gender,height,weight,BMI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The maximum expiratory volume at the time of optional cough is measured three times. The measure to use those connecting the face mask to assessment peak flow meter.
Interventions/Control_2 Optionally cough when is conscious of the breath hold on, to measure the maximum expiratory volume in the same way as in intervention 1.
Interventions/Control_3 Optionally cough when to consciousness on the breath-holding and tongue raise, to measure the peak expiratory flow in the same way as in intervention 1.
Interventions/Control_4 Optionally cough when is conscious of the breath hold asked by pushing the front of the wall, to measure the peak expiratory flow in the same way as in intervention 1.
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
50 years-old >=
Gender Male and Female
Key inclusion criteria history without a healthy adult of respiratory disease
it can be obtained the consent of the research participation by free will in writing from the person
age at the time of obtaining informed consent or more and less than 20 years old 50 years of age
gender: no preference
affiliation: Okayama University who belong to the hospital and Medical Technology Department, Rehabilitation Department
who is physical, mental and social disadvantage by participation in this study do not occur
those who are understanding of the clinical significance and its importance with the present study
Key exclusion criteria women that may be in or pregnancy
a person who has a throat pain
with cold symptoms who
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name tomohiro ikeda
Organization Okayama University Hospital
Division name General Department of Rehabilitation
Zip code
Address Okayama, Okayama Prefecture, Kita-ku, Shikata-cho, 2-5-1
TEL 086-235-7752
Email lirfranjitte@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name tomohiro ikeda
Organization Okayama University Hospital
Division name General Department of Rehabilitation
Zip code
Address Okayama, Okayama Prefecture, Kita-ku, Shikata-cho, 2-5-1
TEL 086-235-7752
Homepage URL
Email lirfranjitte@yahoo.co.jp

Sponsor
Institute Okyama University Hospital
Institute
Department

Funding Source
Organization nothing
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
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 岡山大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 12 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 29 Day
Last modified on
2017 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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