UMIN-CTR Clinical Trial

Basic information
Public title	Nonspecific IgE Potential in Nasal Discharge with Child Sleep Apnea for Diagnosing Allergic Rhinitis
Acronym	Nonspecific IgE Potential in Nasal Discharge with Child Sleep Apnea for Diagnosing Allergic Rhinitis
Scientific Title	Nonspecific IgE Potential in Nasal Discharge with Child Sleep Apnea for Diagnosing Allergic Rhinitis
Scientific Title:Acronym	Nonspecific IgE Potential in Nasal Discharge with Child Sleep Apnea for Diagnosing Allergic Rhinitis
Region	Japan

Condition
Condition	sleep apnea syndrome
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study nonspecific IgE potentilal in nasal discharge as a diagnostic marker for allergic rhinitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Allerwatch
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	nonspecific IgE in nasal discharge
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	1 years-old <=
Age-upper limit	14 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The patient by whom an operation was scheduled. 2. The patient who could get consent from a parent
Key exclusion criteria	1. Person with serious case's infections 2. The person who judged that a study doctor in attendance was unsuitable.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Takeuchi
Organization	Faculty of Medicine, Tottori University
Division name	Department of Otolaryngology, Head and Neck Surgery
Zip code	6838503
Address	86 Nishi-cho, Yonago-city, Tottori
TEL	0859-38-6627
Email	oto3175@med.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	Department of Otolaryngology, Head and Neck Surgery
Zip code	6838503
Address	86 Nishi-cho, Yonago-city, Tottori
TEL	0859-38-6627
Homepage URL
Email	yosuken@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	Tottori university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Medicine, Tottori University
Address	86 Nishi-cho, Yonago-city, Tottori
Tel	0859-33-1111
Email	toridai-chiken@med.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	2017 Year 05 Month 30 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	No longer recruiting
Date of protocol fixation	2016 Year 09 Month 15 Day
Date of IRB	2016 Year 09 Month 16 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2021 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	2017 Year 05 Month 30 Day
Last modified on	2020 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031566