UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040813 |
|---|---|
| Receipt number | R000046594 |
| Scientific Title | Evaluation of the nasal cavity resistance by the spirometry |
| Date of disclosure of the study information | 2020/06/17 |
| Last modified on | 2024/01/12 15:05:51 |
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Basic information
Public title
Evaluation of the nasal cavity resistance by the spirometry
Acronym
Evaluation of the nasal cavity resistance by the spirometry
Scientific Title
Evaluation of the nasal cavity resistance by the spirometry
Scientific Title:Acronym
Evaluation of the nasal cavity resistance by the spirometry
Region
| Japan |
Condition
Condition
Nasal congestion
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the result of the transnasal spirometry with the conventional test result.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal breathing flow / mouth breathing flow correlates with a symptom of the nasal congestion.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
transoral and transnose spirometry
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
The patients with nose symptoms or the nose diseases and healthy volunteers
Key exclusion criteria
Minors or the patients who have difficulty in decision making
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Inoue |
Organization
toho university school of medicine
Division name
Otorhinonalyngology
Zip code
1438541
Address
6-11-1 Omori-nishi Ota-ku Tokyo
TEL
03-3762-4151
akiko.inoue@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Inoue |
Organization
toho university school of medicine
Division name
Otorhinonalyngology
Zip code
1438541
Address
6-11-1 Omori-nishi Ota-ku Tokyo
TEL
03-3762-4151
Homepage URL
akiko.inoue@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
Toho 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
shool of medicine Toho university
Address
5-21-16 Omori-nishi Ota-ku Tokyo
Tel
0337624151
med.rinri@ext.toho-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
| 2020 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046594
