UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Stimulation of the pharynx and elicitation of swallowing: a clinical study for aspiration avoidance
Title of the study (Brief title)	Stimulation of the pharynx and elicitation of swallowing
Region	Japan

Condition
Condition	Dysgeusia
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, roles of sensory inputs from chemoreceptors and mechanoreceptors in the mucosa of the pharynx and larynx in swallowing function are investigated in healthy subjects and patients with dysgeusia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Swallowing interval
Key secondary outcomes	1) VAS for taste sensation 2) Salivary secretion

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	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Stimulation of the pharynx consists of infusion of water or taste solutions through a fine silicone tube inserted into the throat orally.
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	Subjects who give written informed consent before participating in the study Healthy subjects: 1) Subjects without swallowing difficulty 2) Subjects without impairment of taste or olfaction 3) Subjects without neurological disease Patients with dysgeusia due to distortions in taste buds 1) Patients without swallowing difficulty 2) Patients without neurological disease
Key exclusion criteria	1) Subjects who complain of a silicon tube inserted into the throat and show gag behaviors 2) Subjects who had a history of swallowing difficulty
Target sample size	70

Research contact person
Name of lead principal investigator	Masafumi Sakagami
Organization	Hyogo College of Medicine
Division name	Depertment of Otolaryngology- Head and Neck Surgery
Address	1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL	0798-45-6492
Email	msakaga@hyo-med.ac.jp

Public contact
Name of contact person	Tomoko Nishii
Organization	Hyogo College of Medicine
Division name	Depertment of Otolaryngology- Head and Neck Surgery
Address	1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL	0798-45-6492
Homepage URL
Email	tnami@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 14 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035411