UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054347 |
|---|---|
| Receipt number | R000061933 |
| Scientific Title | Effects of olfactory stimulation on saliva secretion and swallowing reflex |
| Date of disclosure of the study information | 2024/05/15 |
| Last modified on | 2024/05/09 11:41:29 |
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Basic information
Public title
Effects of olfactory stimulation on saliva secretion and swallowing reflex
Acronym
Effects of olfactory stimulation on saliva secretion and swallowing reflex
Scientific Title
Effects of olfactory stimulation on saliva secretion and swallowing reflex
Scientific Title:Acronym
Effects of olfactory stimulation on saliva secretion and swallowing reflex
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preventive measures for aspiration pneumonia include maintaining oral hygiene through oral care, enhancing airway sensation with drug therapy, and improving coughing ability through rehabilitation. In particular, as subclinical aspiration during the night is the primary cause of aspiration pneumonia, we believe that maintaining oral hygiene through oral care and the sterilizing effect of saliva are essential. Saliva has the function of regulating the oral environment, and has been shown to have functions such as lubricating, buffering, digestive, and antibacterial effects. In this study, we would like to clarify the changes in saliva volume and the effects on the swallowing reflex when aroma oils such as ginger and lavender are given as olfactory stimuli to young people aged 18 to 23.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Add 3 drops of black pepper, lavender, ginger, and purified water to the tip of the muette stick.The subjects were instructed to bring the muette closer to their nose little by little, stop when they felt the scent, and smell the scent for a specified period of time (60 seconds).After that, the examiner collects saliva from the subject and measures the amount of saliva. Additionally, we measure the RSST.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention period (measurement 6 minutes x 4 times), amount of intervention (3 types of aroma oil and purified water)
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
| 18 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
1)Individuals diagnosed with dysphagia.
2)Individuals with anatomical (static) barriers to swallowing dysfunction.
3)Individuals with conditions affecting smell, such as allergic rhinitis.
4)Individuals who may be pregnant or are currently pregnant or breastfeeding.
5)Individuals experiencing discomfort such as nausea or pain due to dental, tongue, or olfactory stimulation.
6)Individuals wearing dentures.
7)Individuals with dementia or communication impairments that make it difficult to communicate intentions.
8)Individuals objectively assessed as lacking the ability to provide informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | MEGUMI |
| Middle name | |
| Last name | MIYAMOTO |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Science Department of Rehabilitation Division of Speech-Language-Hearing Therapy
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2212
meg-mya@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Nagano |
Organization
Kumamoto Health Science University
Division name
Planning and Personnel Department
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2111
Homepage URL
kikaku@kuamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Kumamoto Health Science University Life Science Ethical Review Board
Address
325 Izumimachi,Kita-ku,Kumamoto
Tel
0962752111
kikaku@kumamoto-hsu.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
| 2024 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061933
