UMIN-CTR Clinical Trial

Basic information
Public title	Infuence of glottic closure on expiratory flow and volume acceleration during coughing
Acronym	Infuence of glottic closure on expiratory flow and volume acceleration during coughing
Scientific Title	Infuence of glottic closure on expiratory flow and volume acceleration during coughing
Scientific Title:Acronym	Infuence of glottic closure on expiratory flow and volume acceleration during coughing
Region	Japan

Condition
Condition	Normal adult
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of glottic closure and its function on expiratory flow and volume acceleration during coughing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak expiratory flow, expiratory volume acceleration
Key secondary outcomes	electromyogram

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Normal adult persons are participate in this study. Subject perform the cough with glottic closure.
Interventions/Control_2	Normal adult persons are participate in this study. Subject perform the cough without glottic closure.
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	Normal adult
Key exclusion criteria	without respiratory patients
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomoya Middle name Last name Akakabe
Organization	Kio University
Division name	Division of Health Science, Graduate School of Health Science
Zip code	635-0832
Address	4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL	0745-54-1601
Email	tomo_1017@hotmail.co.jp

Public contact
Name of contact person	1st name Tomoya Middle name Last name Akakabe
Organization	Kio University
Division name	Division of Health Science, Graduate School of Health Science
Zip code	635-0832
Address	4-2-2 Umami-naka, Koryo-cho,Kitakatsuragi-gun, Nara, Japan
TEL	0745-54-1601
Homepage URL
Email	tomo_1017@hotmail.co.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
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	Kio University
Address	4-2-2 Umami-naka, Koryo-cho,Kitakatsuragi-gun, Nara, Japan
Tel	0745-54-1601
Email	tomo_1017@hotmail.co.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	畿央大学(奈良県)(Kio　University)

Other administrative information
Date of disclosure of the study information	2012 Year 06 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	Open public recruiting
Date of protocol fixation	2012 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 06 Month 26 Day
Last modified on	2020 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009742