UMIN-CTR Clinical Trial

Basic information
Public title	The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Acronym	The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Scientific Title	The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Scientific Title:Acronym	The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of tongue lift movement on hyoid and laryngeal position in healthy volunteers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle activity of supra hyoid muscle Xray image of hyoid bone and laryngeal position
Key secondary outcomes

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	20 years-old <
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Health volunteers who have no dysphagic symptoms
Key exclusion criteria	People having a medical history that causes dysphagia
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Jin Middle name Last name Magara
Organization	Niigata University, Medical & Dental hospital
Division name	Unit of dysphagia rehabilitation
Zip code	9518514
Address	Niigata University Graduate School of Medical and Dental Sciences 2-5274 Gakkocho-dori, Chuo-ku, Nii
TEL	0252272999
Email	jin-m@dent.niigata-u.ac.jp

Public contact
Name of contact person	1st name Jin Middle name Last name Magara
Organization	Niigata University Medical & Dental Hospital
Division name	Unit of dysphagia rehabilitation
Zip code	9518514
Address	Niigata University Graduate School of Medical and Dental Sciences 2-5274 Gakkocho-dori, Chuo-ku, Nii
TEL	0252272999
Homepage URL
Email	jin-m@dent.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of the Niigata University
Address	757 Ichiban-cho Asahimachi-dori Chu-o-ku, Niitata city
Tel	025-227-2005
Email	joho@med.niigata-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2017-0328
Org. issuing International ID_1	2017-0328
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 22 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/epdf/10.1111/joor.12988
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	2018 Year 03 Month 05 Day
Date of IRB	2018 Year 03 Month 06 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Results of young volunteers has been published.

Management information
Registered date	2020 Year 06 Month 22 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035141