UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042875 |
|---|---|
| Receipt number | R000048727 |
| Scientific Title | measurement of intranasal pH of each sinonasal disease |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2024/01/02 19:30:27 |
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Basic information
Public title
The research on whether there are difference between intranasal pH in each sinonasal disease
Acronym
measurement of intranasal pH
Scientific Title
measurement of intranasal pH of each sinonasal disease
Scientific Title:Acronym
measurement of intranasal pH
Region
| Japan |
Condition
Condition
chronic sinusitis, sensorineural olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Respiratory epithelium and olfactory epithelium capable of secreting mucus are present in the nasal cavity and are always covered with mucus. In order to maintain homeostasis, the properties of this mucus also need to be constant. When suffering from nasal sinus disease, the properties of the nasal mucosa and secretions change, but the evaluation at the macroscopic level is limited as to what kind of condition is normal and what kind of condition is abnormal. We focused on the intranasal pH value, which has received little attention so far, and the normal pH has not been determined. We plan to measure pH at specific intranasal sites in healthy subjects, chronic sinusitis, and patients with neurological olfactory dysfunction to find if there are any difference. This study is an exploratory study to investigate the presence or absence of differences, but if differences are found, the average value of each site in healthy subjects will be calculated in the future and compared with patients with chronic sinusitis or olfactory dysfunction. We hope that it will lead to the identification of diseases and the investigation of whether or not the pathological condition can be grasped. Furthermore, the pH value measurement of the nasal cavity is a less invasive test that can be performed in parallel with the anterior nasal speculum that is usually performed in a medical examination, and may be applied as a tool for diagnosis and judgment of therapeutic effect in the future.
Basic objectives2
Others
Basic objectives -Others
The nasal cavities of healthy subjects and patients with chronic sinusitis and neurological olfactory dysfunction were observed with an anterior nasal speculum, and olfactory sensation questions and questionnaires will be conducted. Intranasal pH of nasal floor, nasal septum, inferior turbinate, middle turbinate, olfactory cleft will be measured with a pH measuring catheter. In patients with chronic sinusitis and neurological olfactory dysfunction, if nasal flexible fiberscopy, CT, blood tests, or olfactory tests have been performed in normal practice, information will also be collected.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
anterior nasal examination, nasal pH measurement
Key secondary outcomes
Healthy subjects: olfactory questionnaire (VAS), daily odor questionnaire, card-type olfactory identification ability test (Open Essence), Likert scale
Patients with nasal sinus disease, neurological olfactory disorder: CT, nasal fiber, blood test in addition to the above
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
To measure nasal pH of each participant.
We will measure nasal floor, nasal septum, inferior turbinate, middle turbinate, olfactory cleftIt on bilateral side. The pH value will be measured 3 times for each sight and will be mean value will be recorded. The measurement time is one time, for healthy control on specific day and for chronic sinusitis patients and sensorineural olfactory dysfunction patients for their appointment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy control of adult people from 18 years old.
Patient with chronic sinusitis and sensoryneural olfactory disfunction.
Key exclusion criteria
Patient who cannot understand this research
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Mori |
Organization
JIkei University School of Medicine
Division name
Otorhinolaryngology Department
Zip code
105-8471
Address
Shinbashi3-19-18, Minatoku, Tokyo
TEL
03-3433-1111
morieri@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Sekine |
Organization
Jikei University School of Medicine
Division name
Otorhinolaryngology Department
Zip code
105-8471
Address
Shinbashi3-19-18, Minatoku, Tokyo
TEL
03-3433-1111
Homepage URL
rmsekine@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine, Otorhinolaryngology department
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University School of Medicine
Address
Shinbashi3-19-18, Minatoku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 05 | 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
| Delay expected |
Results Delay Reason
Because of COVID19 pandemic, we had difficulty collecting patients.
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
Suspended
Date of protocol fixation
| 2020 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research project has been extended
Management information
Registered date
| 2020 | Year | 12 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048727
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