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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042875
Receipt No. R000048727
Scientific Title measurement of intranasal pH of each sinonasal disease
Date of disclosure of the study information 2021/01/05
Last modified on 2020/12/29

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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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with chronic sinusitis and sensoryneural olfactory disfunction.
Key exclusion criteria Patient who cannot understand this research
Target sample size 36

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
Email 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
Email rmsekine@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

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
Email 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
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
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
2021 Year 09 Month 01 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 12 Month 29 Day
Last modified on
2020 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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