UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031297 |
|---|---|
| Receipt number | R000035411 |
| Scientific Title | Stimulation of the pharynx and elicitation of swallowing: a clinical study for aspiration avoidance |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2018/02/14 14:27:06 |
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Basic information
Public title
Stimulation of the pharynx and elicitation of swallowing: a clinical study for aspiration avoidance
Acronym
Stimulation of the pharynx and elicitation of swallowing
Scientific Title
Stimulation of the pharynx and elicitation of swallowing: a clinical study for aspiration avoidance
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masafumi Sakagami |
Organization
Hyogo College of Medicine
Division name
Depertment of Otolaryngology- Head and Neck Surgery
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL
0798-45-6492
msakaga@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Nishii |
Organization
Hyogo College of Medicine
Division name
Depertment of Otolaryngology- Head and Neck Surgery
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo Japan
TEL
0798-45-6492
Homepage URL
tnami@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035411
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| Registered date | File name |
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| Registered date | File name |
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