UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038957 |
|---|---|
| Receipt number | R000044404 |
| Scientific Title | Evaluation of nasal cavity in Japanese adults by Acoustic rhinometry |
| Date of disclosure of the study information | 2019/12/23 |
| Last modified on | 2023/07/09 23:08:00 |
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Basic information
Public title
Evaluation of nasal cavity in Japanese adults by Acoustic rhinometry
Acronym
Evaluation of nasal cavity in Japanese adults by Acoustic rhinometry
Scientific Title
Evaluation of nasal cavity in Japanese adults by Acoustic rhinometry
Scientific Title:Acronym
Evaluation of nasal cavity in Japanese adults by Acoustic rhinometry
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the reference values for nasal cavity by objectively measuring in Japanese adults at multiple facilities
Basic objectives2
Others
Basic objectives -Others
To create basic materials useful for public health
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nasal cavity
Key secondary outcomes
minimal cross-sectional area
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 |
Interventions/Control_1
Acoustic rhinometry
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those whose grandparents are Japanese
2) Men and women aged between 20 and 70 at the time of consent
3) Those who do not have a sense of nose congestion
4) Those who have not drunk the day before the measurement
5) The subject who obtained the consent of the research subject
Key exclusion criteria
1) Patients with nasal sinus disease or upper respiratory tract disease
2) Patients with history of surgery or trauma due to nasal sinus disease
3) Those who have systemic diseases that may affect nasal breathing
4) Patients who have medications that affect nasal ventilation
5) Those who are currently smoking
6) Pregnant or potential pregnant woman
7) Others who the investigator or coordinator deems inappropriate as a research subject
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Takeuchi |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6627
oto3175@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6627
Homepage URL
yosuken@tottori-u.ac.jp
Sponsor or person
Institute
Tottori university
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Asahikawa Medical University Hospital
2) Ota Memorial Sleep Center
3) Kawasaki Medical School Hospital
4) Kitasato University Hospital
5) Kitasato University Medical Center
6) Saitama Medical University Hospital
7) Dokkyo Medical University
8) Nippon Medical School Musashikosugi Hospital
9) Hiroshima University Hospital
10) Fukushima Medical University Hospital
11) Fukuyama Medical Center
12) Fujita Health University Hospital
13) Fujita Health University Bantane Hospital
14) Mie University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori university
Address
36-1 Nishi-cho, Yonago
Tel
0859-38-7108
me-kenkyu@ml.adm.tottori-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
| 2019 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | 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
| 2019 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044404
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
