UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	effects of tongue elevation and pushing has on the optional cough force
Title of the study (Brief title)	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	tomohiro ikeda
Organization	Okayama University Hospital
Division name	General Department of Rehabilitation
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	tomohiro ikeda
Organization	Okayama University Hospital
Division name	General Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025486