UMIN-CTR Clinical Trial

Basic information
Public title	Modified swallowing to strengthen laryngeal closure
Acronym	Modified swallowing to strengthen laryngeal closure
Scientific Title	Modified super-supraglottic swallow to strengthen laryngeal closure
Scientific Title:Acronym	mSSGS
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effect of modified super-supraglottic swallow
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distance between epiglottis and arytenoid
Key secondary outcomes	position and movement in the pharynx and larynx; rate of complete laryngeal closure; presence or absence of penetration and aspiration; seven grade Likert scale about ease of the procedure

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	super-supraglottic swallow with or without head flexion
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy subjects who gave written informed consent
Key exclusion criteria	Subjects who had a history of stroke, neuromuscular diseases, diseases in pharynx or larynx, respiratory diseases, or upper digestive tract disorders. Speech therapists.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Otaka
Organization	Fujita Health University
Division name	Dept. of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL	0562-93-2167
Email	fhur_2019@yahoo.co.jp

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Kagaya
Organization	Fujita Health University
Division name	Dept. of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL	0562-93-2167
Homepage URL
Email	hkagaya2@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
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	Institutional Review Board of Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel	0562-93-2865
Email	f-irb@fujita-hu.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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 22 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	2020 Year 08 Month 08 Day
Date of IRB	2020 Year 08 Month 08 Day
Anticipated trial start date	2021 Year 10 Month 22 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 22 Day
Last modified on	2021 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052333