UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057892 |
|---|---|
| Receipt number | R000066168 |
| Scientific Title | Investigation of olfactory perception using a nasal airflow control device |
| Date of disclosure of the study information | 2025/05/17 |
| Last modified on | 2025/05/17 13:53:43 |
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Basic information
Public title
Investigation of olfactory perception using a nasal airflow control device
Acronym
Olfactory airflow device
Scientific Title
Investigation of olfactory perception using a nasal airflow control device
Scientific Title:Acronym
Olfactory airflow device
Region
| Japan |
Condition
Condition
olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients who have undergone laryngectomy breathe through a permanent tracheostomy, resulting in the loss of airflow to the nasal cavity. As a result, odor molecules cannot reach the olfactory mucosa, and the patient is unable to perceive odors. Our research group is conducting studies using an olfactory presentation device that can deliver olfactory stimuli synchronized with exhalation and inhalation through the nostrils. We aim to develop a device that controls airflow within the nasal cavity and verify whether laryngectomy patients can regain their sense of smell through its use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After wearing the nasal airflow control device, we will evaluate olfactory recovery through self-reported perceptions and olfactory tests at 1 hour and 2 hours post-device application.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nasal airflow control experiment in laryngectomy patients Using a device that controls nasal airflow, air is drawn through a tube inserted into the nostrils by several millimeters to several centimeters, and the odor of food (such as candy or gummy candies) containing odor in the oral cavity is delivered to the nasal cavity (Figure 1). A seal can be attached to the tube to prevent airflow loss. Using this device, we will evaluate the intensity, category, and impression of olfactory perception. Additionally, we will investigate whether the perceived deliciousness of daily meals can be improved.
Data will be obtained through psychophysical measurement methods and subjective reports. The experiment will be conducted one-on-one with the researcher in a private room. The experiment will take approximately 60 minutes.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have undergone laryngectomy and healthy individuals
2) Ages 18 to 75
3) Written informed consent has been obtained from the patient after providing sufficient information regarding the study.
Key exclusion criteria
Patients who are deemed unsuitable as research subjects by the principal investigator or research collaborator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Mie University
Division name
Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
0592315028
m-koba@doc.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Mie University
Division name
Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine
Zip code
514-0065
Address
2-174 Edobashi, Tsu, Mie
TEL
0592245488
Homepage URL
m-koba@doc.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Ritsumeikan 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
Mie University Hospital Ethics Committee
Address
2-174 Edobashi, Tsu, Mie
Tel
059-231-5045
kk-sien@med.mie-u.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
| 2025 | Year | 05 | Month | 17 | 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
| 2025 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066168
